A Phase 3 interventional study of CAB LA+RPV LA in HIV Infections, sponsored by ViiV Healthcare. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 3, Interventional, and Other
Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 115 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →ViiV Healthcare is the lead sponsor of 265 studies on the registry; 16 are open to participants now.
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All Participants eligible for enrolment in the study must meet all of the following criteria:
Acceptable stable ARV regimens prior to Screening include 2 NRTIs plus:
Any suppressed participants on a triple ART regimen for at least 6 months who had their regimen switched to a 2DR of dolutegravir (DTG)/RPV
- Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL in the 12 months prior to Screening: at least one within 6 months prior to Screening;
A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test at screen and at Day 1), not lactating, and at least one of the following conditions applies:
Pre-menopausal females with one of the following:
Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
Exclusion Criteria:
Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows:
Participants with HCV co-infection will be allowed entry into this study if:
In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility
Concomitant Medications
Treatment with any of the following agents within 28 days of Day 1:
HIV-infected subjects receiving CAB LA+RPV LA will be included in this arm.
Drug: CAB LA+RPV LA
Subjects will receive one tablet of CAB 30 milligram(mg) + RPV 25 mg once daily from Day 1 for 1 month. During month 1, subjects will receive 600 mg of CAB LA injection+ 900 mg of RPV LA injection. Following Month 1, subjects will receive 400mg of CAB LA + 600mg of RPV LA at each subsequent injection.
Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Change From Baseline in AIM Total Score in Staff Study Participants at Month 12
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4
AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12
AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4
IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Change From Baseline in IAM Score in Staff Study Participants at Month 12
IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Change From Baseline in IAM Score in Participants With HIV Infection at Month 4
IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Change From Baseline in IAM Score in Participants With HIV Infection at Month 12
IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4
FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Change From Baseline for FIM Total Score in Staff Study Participants at Month 12
FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented.
Time frame: At Month 4
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented.
Time frame: At Month 12
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
Time frame: Baseline and Month 4
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
Time frame: Baseline and Month 12
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented.
Time frame: At Month 12
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented.
Time frame: At Month 12
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time frame: Up to 6 months
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time frame: Up to 6 months
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time frame: Up to 6 months
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
Time frame: At Month 4
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
Time frame: At Month 12
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented.
Time frame: At Month 4
Number of Participants Receiving Injections Within Target Window at Month 4
Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date.
Time frame: At Month 4
Number of Participants Receiving Injections Within Target Window at Month 12
Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date.
Time frame: At Month 12
Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts)
Time frame: At Month 12
HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time frame: At Month 1
HIV-TSQs Scores at Month 4
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time frame: At Month 4
HIV-TSQs Scores at Month 12
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time frame: At Month 12
Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit
The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable.
Time frame: At Month 12
Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit
Number of participants with the reported time spent in clinic/practice for each injection visit is presented.
Time frame: At Month 12
Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment
Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable.
Time frame: At Month 12
Length of Participant Visit
Length of visit was calculated by subtracting the arrival time (Lead time \[actual start time of appointment - arrival time\] + process time \[actual end time of appointment - actual start time of appointment\]) from actual end time of appointment.
Time frame: At Months 1, 5 and 11
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach.
Time frame: Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage value presented has been rounded off.
Time frame: Months 1, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12, Month 13, Month 15, Month 16, Month 18, Month 19, Month 21, Month 22, Month 24, Month 25, Month 27, Month 28 and Month 30
Percentage of Participants With Confirmed Virologic Failure (CVF)
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (\>=)200 copies/mL after prior suppression to \<200 copies/mL.
Time frame: Up to 30 months
Number of Participants With Treatment Emergent Genotypic Resistance to CAB and RPV
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent genotypic resistance is summarized.
Time frame: Up to 30 months
Number of Participants With Treatment Emergent Phenotypic Resistance to CAB and RPV
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent phenotypic resistance is summarized.
Time frame: Up to 30 months
Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (\>=5%) non-SAEs are presented. Adverse events which were not serious have been considered as non-serious adverse events.
Time frame: Up to 30 months
Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off.
Time frame: Up to 30 months
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time frame: Up to Month 12
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. The parameters were graded according to the DAIDS toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time frame: Up to 30 months
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time frame: Up to Month 12
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST, bilirubin, CO2, CK, creatinine, direct bilirubin, Glomerular filtration rate (GFR) from Creatinine (Creat) Adjusted (Adj) using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), GFR From Creat Adj for body surface area (BSA), glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time frame: Up to 30 months
Number of Participants With Urinalysis Result of Potential Clinical Importance
Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
Time frame: Up to Month 12
Number of Participants With Urinalysis Result of Potential Clinical Importance Through End of Study
Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
Time frame: Up to 30 months
Number of Participants With Injection Site Reactions (ISRs) Over Time
Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
Time frame: Months 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV)
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count.
Time frame: Up to Month 12
Absolute Values of Hematology Parameter: RBC Count
Blood samples were collected to analyze the hematology parameter: RBC count.
Time frame: Up to Month 12
Absolute Values of Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: Hemoglobin
Time frame: Up to Month 12
Absolute Values of Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1)
Time frame: Up to Month 12
Absolute Values of Hematology Parameter: Erythrocytes MCV
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
Time frame: Up to Month 12
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count.
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: RBC count.
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Hemoglobin.
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1).
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
Time frame: Months 15, 18, 21, 24, 27, 30
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Clinical Laboratory Parameter: Lipase
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Clinical Laboratory Parameter: Albumin
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and up to Month 12
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Blood samples were collected for the analysis of clinical chemistry parameter-Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
Time frame: Up to Month 12
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
Time frame: Up to Month 12
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
Time frame: Up to Month 12
Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA
Time frame: Up to Month 12
Absolute Values of Clinical Laboratory Parameter: Lipase
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase.
Time frame: Up to Month 12
Absolute Values of Clinical Laboratory Parameter: Albumin
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin.
Time frame: Up to Month 12
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA.
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30
Blood samples were collected for the analysis of clinical chemistry parameter-Lipase.
Time frame: Months 15, 18, 21, 24, 27, 30
Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Blood samples were collected for the analysis of clinical chemistry parameter-Albumin.
Time frame: Months 15, 18, 21, 24, 27, 30
Change From Baseline in Urinalysis Parameters: Urine Albumin to Creatinine Ratio
Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted.
Time frame: Baseline and up to Month 12
Change From Baseline in Urinalysis Parameters: Urine Protein to Creatinine Ratio
Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted.
Time frame: Baseline and up to Month 12
Change From Baseline in Urinalysis Parameters: Urine Phosphate
Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted.
Time frame: Baseline and up to Month 12
Total 115 participants were enrolled in study and received study treatment. The 24 study staff population(HIV care providers,nurses/staff performing CAB+LA injections administrators/clinic managers)is not considered participants in the study and were not counted in the enrollment number nor reported in any modules that are considered for enrolled participants as study staff didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections.
| Milestone | Participants With HIV Infection |
|---|---|
| Started | 115 |
| Completed | 102 |
| Not completed | 13 |
| Withdrew: Adverse event | 5 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 4 |
| Milestone | Participants With HIV Infection |
|---|---|
| Started | 101 |
| Completed | 95 |
| Not completed | 6 |
| Withdrew: Adverse event | 2 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Milestone | Participants With HIV Infection |
|---|---|
| Started | 10 |
| Completed | 7 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 2 |
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Staff Study Participants |
|---|---|
| Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4 | 0.00 ± 0.42 |
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Staff Study Participants |
|---|---|
| Change From Baseline in AIM Total Score in Staff Study Participants at Month 12 | 0.02 ± 0.52 |
AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Participants With HIV Infection |
|---|---|
| Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4 | 0.03 ± 0.74 |
AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Participants With HIV Infection |
|---|---|
| Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12 | 0.19 ± 0.52 |
IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Staff Study Participants |
|---|---|
| Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4 | -0.03 ± 0.50 |
IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Staff Study Participants |
|---|---|
| Change From Baseline in IAM Score in Staff Study Participants at Month 12 | 0.10 ± 0.43 |
IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Participants With HIV Infection |
|---|---|
| Change From Baseline in IAM Score in Participants With HIV Infection at Month 4 | 0.05 ± 0.78 |
IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Participants With HIV Infection |
|---|---|
| Change From Baseline in IAM Score in Participants With HIV Infection at Month 12 | 0.19 ± 0.58 |
FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Staff Study Participants |
|---|---|
| Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4 | -0.02 ± 0.63 |
FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Scores on a scale | Staff Study Participants |
|---|---|
| Change From Baseline for FIM Total Score in Staff Study Participants at Month 12 | 0.07 ± 0.69 |
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented.
| Participants | Staff Study Participants |
|---|---|
| Website for clinical staff, EH | 2 |
| Website for clinical staff, VH | 3 |
| Website for clinical staff, SH | 3 |
| Website for clinical staff, ALH | 5 |
| Website for clinical staff, NAAH | 1 |
| Website for clinical staff, NA | 10 |
| Video on giving CAB + RPV LA injection, EH | 3 |
| Video on giving CAB + RPV LA injection, VH | 6 |
| Video on giving CAB + RPV LA injection, SH | 4 |
| Video on giving CAB + RPV LA injection, ALH | 2 |
| Video on giving CAB + RPV LA injection, NAAH | 0 |
| Video on giving CAB + RPV LA injection, NA | 9 |
| How to use new packaging card, EH | 0 |
| How to use new packaging card, VH | 6 |
| How to use new packaging card, SH | 3 |
| How to use new packaging card, ALH | 3 |
| How to use new packaging card, NAAH | 1 |
| How to use new packaging card, NA | 11 |
| Study factsheet for healthcare providers, EH | 1 |
| Study factsheet for healthcare providers, VH | 4 |
| Study factsheet for healthcare providers, SH | 8 |
| Study factsheet for healthcare providers, ALH | 1 |
| Study factsheet for healthcare providers, NAAH | 1 |
| Study factsheet for healthcare providers, NA | 9 |
| Consultation aid, EH | 0 |
| Consultation aid, VH | 4 |
| Consultation aid, SH | 4 |
| Consultation aid, ALH | 2 |
| Consultation aid, NAAH | 1 |
| Consultation aid, NA | 13 |
| Reminder-electronic (e)-application (app), EH | 1 |
| Reminder e-app, VH | 2 |
| Reminder e-app, SH | 1 |
| Reminder e-app, ALH | 2 |
| Reminder e-app, NAAH | 0 |
| Reminder e-app, NA | 18 |
| Reminder short message service (SMS)/text, EH | 1 |
| Reminder SMS/text, VH | 1 |
| Reminder SMS/text, SH | 1 |
| Reminder SMS/text, ALH | 2 |
| Reminder SMS/text, NAAH | 0 |
| Reminder SMS/text, NA | 19 |
| Face to face (F2F) training by healthcare staff, EH | 5 |
| F2F training by healthcare staff, VH | 6 |
| F2F training by healthcare staff, SH | 3 |
| F2F training by healthcare staff, ALH | 1 |
| F2F training by healthcare staff, NAAH | 0 |
| F2F training by healthcare staff, NA | 9 |
| Facilitation group calls, EH | 0 |
| Facilitation group calls, VH | 0 |
| Facilitation group calls, SH | 7 |
| Facilitation group calls, ALH | 8 |
| Facilitation group calls, NAAH | 4 |
| Facilitation group calls, NA | 5 |
| Web-based (WB) treatment planner, EH | 4 |
| WB treatment planner, VH | 5 |
| WB treatment planner, SH | 1 |
| WB treatment planner, ALH | 1 |
| WB treatment planner, NAAH | 1 |
| WB treatment planner, NA | 12 |
| WB health clinic capacity planning tool, EH | 0 |
| WB health clinic capacity planning tool, VH | 1 |
| WB health clinic capacity planning tool, SH | 0 |
| WB health clinic capacity planning tool, ALH | 0 |
| WB health clinic capacity planning tool, NAAH | 1 |
| WB health clinic capacity planning tool, NA | 22 |
| Injection flashcard for participants, EH | 2 |
| Injection flashcard for participants, VH | 2 |
| Injection flashcard for participants, SH | 5 |
| Injection flashcard for participants, ALH | 3 |
| Injection flashcard for participants, NAAH | 0 |
| Injection flashcard for participants, NA | 12 |
| Website for participants, EH | 0 |
| Website for participants, VH | 3 |
| Website for participants, SH | 4 |
| Website for participants, ALH | 2 |
| Website for participants, NAAH | 0 |
| Website for participants, NA | 15 |
| What to expect factsheet for participants, EH | 1 |
| What to expect factsheet for participants, VH | 5 |
| What to expect factsheet for participants, SH | 7 |
| What to expect factsheet for participants, ALH | 2 |
| What to expect factsheet for participants, NAAH | 0 |
| What to expect factsheet for participants, NA | 9 |
| Participant handbook, EH | 3 |
| Participant handbook, VH | 3 |
| Participant handbook, SH | 5 |
| Participant handbook, ALH | 0 |
| Participant handbook, NAAH | 1 |
| Participant handbook, NA | 12 |
| Frequently asked questions (FAQs) chatbot, EH | 0 |
| FAQs chatbot, VH | 1 |
| FAQs chatbot, SH | 3 |
| FAQs chatbot, ALH | 1 |
| FAQs chatbot, NAAH | 1 |
| FAQs chatbot, NA | 18 |
| Trial guide app, EH | 0 |
| Trial guide app, VH | 1 |
| Trial guide app, SH | 2 |
| Trial guide app, ALH | 1 |
| Trial guide app, NAAH | 1 |
| Trial guide app, NA | 19 |
| Video-what to expect, EH | 7 |
| Video-what to expect, VH | 4 |
| Video-what to expect, SH | 1 |
| Video-what to expect, ALH | 3 |
| Video-what to expect, NAAH | 1 |
| Video-what to expect, NA | 8 |
| Hot and cold packs for participants, EH | 5 |
| Hot and cold packs for participants, VH | 5 |
| Hot and cold packs for participants, SH | 6 |
| Hot and cold packs for participants, ALH | 2 |
| Hot and cold packs for participants, NAAH | 0 |
| Hot and cold packs for participants, NA | 6 |
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented.
| Participants | Staff Study Participants |
|---|---|
| Website for clinical staff, EH | 2 |
| Website for clinical staff, VH | 2 |
| Website for clinical staff, SH | 6 |
| Website for clinical staff, ALH | 0 |
| Website for clinical staff, NAAH | 0 |
| Website for clinical staff, NA | 13 |
| Video on giving CAB + RPV LA injection, EH | 4 |
| Video on giving CAB + RPV LA injection, VH | 6 |
| Video on giving CAB + RPV LA injection, SH | 7 |
| Video on giving CAB + RPV LA injection, ALH | 0 |
| Video on giving CAB + RPV LA injection, NAAH | 0 |
| Video on giving CAB + RPV LA injection, NA | 6 |
| How to use new packaging card, EH | 1 |
| How to use new packaging card, VH | 3 |
| How to use new packaging card, SH | 5 |
| How to use new packaging card, ALH | 0 |
| How to use new packaging card, NAAH | 0 |
| How to use new packaging card, NA | 14 |
| Study factsheet for healthcare providers, EH | 1 |
| Study factsheet for healthcare providers, VH | 6 |
| Study factsheet for healthcare providers, SH | 4 |
| Study factsheet for healthcare providers, ALH | 1 |
| Study factsheet for healthcare providers, NAAH | 0 |
| Study factsheet for healthcare providers, NA | 11 |
| Consultation aid, EH | 1 |
| Consultation aid, VH | 1 |
| Consultation aid, SH | 2 |
| Consultation aid, ALH | 5 |
| Consultation aid, NAAH | 0 |
| Consultation aid, NA | 14 |
| Reminder e-app, EH | 0 |
| Reminder e-app, VH | 1 |
| Reminder e-app, SH | 0 |
| Reminder e-app, ALH | 0 |
| Reminder e-app, NAAH | 1 |
| Reminder e-app, NA | 21 |
| Reminder SMS/text, EH | 1 |
| Reminder SMS/text, VH | 1 |
| Reminder SMS/text, SH | 0 |
| Reminder SMS/text, ALH | 1 |
| Reminder SMS/text, NAAH | 2 |
| Reminder SMS/text, NA | 18 |
| F2F training by healthcare staff, EH | 6 |
| F2F training by healthcare staff, VH | 10 |
| F2F training by healthcare staff, SH | 3 |
| F2F training by healthcare staff, ALH | 0 |
| F2F training by healthcare staff, NAAH | 0 |
| F2F training by healthcare staff, NA | 4 |
| Facilitation group calls, EH | 1 |
| Facilitation group calls, VH | 1 |
| Facilitation group calls, SH | 5 |
| Facilitation group calls, ALH | 5 |
| Facilitation group calls, NAAH | 4 |
| Facilitation group calls, NA | 7 |
| WB treatment planner, EH | 4 |
| WB treatment planner, VH | 1 |
| WB treatment planner, SH | 4 |
| WB treatment planner, ALH | 0 |
| WB treatment planner, NAAH | 1 |
| WB treatment planner, NA | 13 |
| WB health clinic capacity planning tool, EH | 0 |
| WB health clinic capacity planning tool, VH | 0 |
| WB health clinic capacity planning tool, SH | 2 |
| WB health clinic capacity planning tool, ALH | 1 |
| WB health clinic capacity planning tool, NAAH | 0 |
| WB health clinic capacity planning tool, NA | 20 |
| Injection flashcard for participants, EH | 2 |
| Injection flashcard for participants, VH | 7 |
| Injection flashcard for participants, SH | 2 |
| Injection flashcard for participants, ALH | 1 |
| Injection flashcard for participants, NAAH | 0 |
| Injection flashcard for participants, NA | 11 |
| Website for participants, EH | 0 |
| Website for participants, VH | 3 |
| Website for participants, SH | 3 |
| Website for participants, ALH | 0 |
| Website for participants, NAAH | 0 |
| Website for participants, NA | 17 |
| What to expect factsheet for participants, EH | 2 |
| What to expect factsheet for participants, VH | 7 |
| What to expect factsheet for participants, SH | 6 |
| What to expect factsheet for participants, ALH | 1 |
| What to expect factsheet for participants, NAAH | 0 |
| What to expect factsheet for participants, NA | 7 |
| Participant handbook, EH | 1 |
| Participant handbook, VH | 5 |
| Participant handbook, SH | 5 |
| Participant handbook, ALH | 2 |
| Participant handbook, NAAH | 0 |
| Participant handbook, NA | 10 |
| FAQs chatbot, EH | 0 |
| FAQs chatbot, VH | 1 |
| FAQs chatbot, SH | 0 |
| FAQs chatbot, ALH | 1 |
| FAQs chatbot, NAAH | 1 |
| FAQs chatbot, NA | 20 |
| Trial guide app, EH | 0 |
| Trial guide app, VH | 0 |
| Trial guide app, SH | 0 |
| Trial guide app, ALH | 0 |
| Trial guide app, NAAH | 1 |
| Trial guide app, NA | 22 |
| Video-what to expect, EH | 4 |
| Video-what to expect, VH | 7 |
| Video-what to expect, SH | 3 |
| Video-what to expect, ALH | 0 |
| Video-what to expect, NAAH | 0 |
| Video-what to expect, NA | 9 |
| Hot and cold packs for participants, EH | 6 |
| Hot and cold packs for participants, VH | 6 |
| Hot and cold packs for participants, SH | 6 |
| Hot and cold packs for participants, ALH | 3 |
| Hot and cold packs for participants, NAAH | 0 |
| Hot and cold packs for participants, NA | 2 |
BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
| Participants | Staff Study Participants |
|---|---|
| Interest in the new treatment, FPB | 15 |
| Interest in the new treatment, SPB | 6 |
| Interest in the new treatment, MPB | 3 |
| Incentives for clinical practice change, FPB | 15 |
| Incentives for clinical practice change, SPB | 3 |
| Incentives for clinical practice change, MPB | 6 |
| Ability to keep monthly appointments (apts), FPB | 14 |
| Ability to keep monthly appointments, SPB | 5 |
| Ability to keep monthly appointments, MPB | 5 |
| Failing due to missed doses/injection apts, FPB | 13 |
| Failing due to missed doses/injection apts, SPB | 9 |
| Failing due to missed doses/injection apts, MPB | 2 |
| Lack of familiarity with tools/resources, FPB | 13 |
| Lack of familiarity with tools/resources, SPB | 8 |
| Lack of familiarity with tools/resources, MPB | 3 |
| Transportation for monthly apts, FPB | 12 |
| Transportation for monthly apts, SPB | 10 |
| Transportation for monthly apts, MPB | 2 |
| Injection (Inj)/pain soreness, FPB | 12 |
| Injection/pain soreness, SPB | 10 |
| Injection/pain soreness, MPB | 2 |
| Rescheduling missed injections, FPB | 12 |
| Rescheduling missed injections, SPB | 9 |
| Rescheduling missed injections, MPB | 3 |
| Time for new method implementation CAB+RPV LA, FPB | 12 |
| Time for new method implementation CAB+RPV LA, SPB | 11 |
| Time for new method implementation CAB+RPV LA, MPB | 1 |
| Flagging/awareness of missed injection visits, FPB | 11 |
| Flagging/awareness of missed injection visits, SPB | 9 |
| Flagging/awareness of missed injection visits, MPB | 4 |
| Competing clinic priorities, FPB | 11 |
| Competing clinic priorities, SPB | 10 |
| Competing clinic priorities, MPB | 3 |
| Manage for inj visits with other care need, FPB | 10 |
| Manage for inj visits with other care need,SPB | 8 |
| Manage for inj visit with other care need, MPB | 6 |
| Transition from oral to injection treatment, FPB | 10 |
| Transition from oral to injection treatment, SPB | 13 |
| Transition from oral to injection treatment, MPB | 1 |
| Time to administer the injection, FPB | 10 |
| Time to administer the injection, SPB | 10 |
| Time to administer the injection, MPB | 4 |
| Number of exam rooms for injection, FPB | 9 |
| Number of exam rooms for injection, SPB | 9 |
| Number of exam rooms for injection, MPB | 6 |
| Staff resourcing for clinic flow, FPB | 9 |
| Staff resourcing for clinic flow, SPB | 8 |
| Staff resourcing for clinic flow, MPB | 7 |
| Staff buy-in, FPB | 9 |
| Staff buy-in, SPB | 13 |
| Staff buy-in, MPB | 2 |
| Staff preparation, FPB | 9 |
| Staff preparation, SPB | 13 |
| Staff preparation, MPB | 2 |
| Scheduling of apt reminders, FPB | 8 |
| Scheduling of apt reminders, SPB | 12 |
| Scheduling of apt reminders, MPB | 4 |
| Answering questions between visits, FPB | 7 |
| Answering questions between visits, SPB | 11 |
| Answering questions between visits, MPB | 6 |
| Scheduling of monthly apts, FPB | 7 |
| Scheduling of monthly apts, SPB | 13 |
| Scheduling of monthly apts, MPB | 4 |
| Leadership support, FPB | 6 |
| Leadership support, SPB | 14 |
| Leadership support, MPB | 4 |
| Storage/refrigeration, FPB | 5 |
| Storage/refrigeration, SPB | 11 |
| Storage/refrigeration, MPB | 8 |
BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
| Percentage of participants | Staff Study Participants |
|---|---|
| Failing due to missed doses/injection apts, FPB | 78.1 |
| Failing due to missed doses/injection apts, SPB | 13.0 |
| Failing due to missed doses/injection apts, MPB | 8.7 |
| Flagging/awareness of missed injection visits, FPB | 69.5 |
| Flagging/awareness of missed injection visits, SPB | 26.1 |
| Flagging/awareness of missed injection visits, MPB | 4.3 |
| Ability to keep monthly appointments, FPB | 65.2 |
| Ability to keep monthly appointments, SPB | 34.8 |
| Ability to keep monthly appointments, MPB | 0.0 |
| Transportation for monthly apts, FPB | 60.8 |
| Transportation for monthly apts, SPB | 34.8 |
| Transportation for monthly apts, MPB | 4.3 |
| Time for new method implementation CAB+RPV LA, FPB | 60.8 |
| Time for new method implementation CAB+RPV LA, SPB | 26.1 |
| Time for new method implementation CAB+RPV LA, MPB | 13.0 |
| Incentives for clinical practice change, FPB | 60.7 |
| Incentives for clinical practice change, SPB | 21.7 |
| Incentives for clinical practice change, MPB | 17.4 |
| Interest in the new treatment, FPB | 56.5 |
| Interest in the new treatment, SPB | 26.1 |
| Interest in the new treatment, MPB | 17.4 |
| Transition from oral to injection treatment, FPB | 56.5 |
| Transition from oral to injection treatment, SPB | 39.1 |
| Transition from oral to injection treatment, MPB | 4.3 |
| Competing clinic priorities, FPB | 52.1 |
| Competing clinic priorities, SPB | 43.5 |
| Competing clinic priorities, MPB | 4.3 |
| Manage for inj visits with other care need, FPB | 52.1 |
| Manage for inj visits with other care need,SPB | 43.5 |
| Manage for inj visit with other care need, MPB | 4.3 |
| Number of exam rooms for injection, FPB | 52.1 |
| Number of exam rooms for injection, SPB | 21.7 |
| Number of exam rooms for injection, MPB | 26.1 |
| Staff resourcing for clinic flow, FPB | 52.1 |
| Staff resourcing for clinic flow, SPB | 30.4 |
| Staff resourcing for clinic flow, MPB | 17.4 |
| Scheduling of apt reminders, FPB | 52.1 |
| Scheduling of apt reminders, SPB | 34.8 |
| Scheduling of apt reminders, MPB | 13.0 |
| Time to administer the injection, FPB | 47.8 |
| Time to administer the injection, SPB | 43.5 |
| Time to administer the injection, MPB | 8.7 |
| Lack of familiarity with tools/resources, FPB | 47.7 |
| Lack of familiarity with tools/resources, SPB | 39.1 |
| Lack of familiarity with tools/resources, MPB | 13.0 |
| Rescheduling missed injections, FPB | 47.7 |
| Rescheduling missed injections, SPB | 39.1 |
| Rescheduling missed injections, MPB | 13.0 |
| Staff preparation, FPB | 43.4 |
| Staff preparation, SPB | 47.8 |
| Staff preparation, MPB | 8.7 |
| Scheduling of monthly apts, FPB | 43.4 |
| Scheduling of monthly apts, SPB | 30.4 |
| Scheduling of monthly apts, MPB | 8.7 |
| Answering questions between visits, FPB | 39.1 |
| Answering questions between visits, SPB | 43.5 |
| Answering questions between visits, MPB | 17.4 |
| Leadership support, FPB | 39.0 |
| Leadership support, SPB | 43.5 |
| Leadership support, MPB | 17.4 |
| Injection/pain soreness, FPB | 34.8 |
| Injection/pain soreness, SPB | 56.5 |
| Injection/pain soreness, MPB | 8.7 |
| Staff buy-in, FPB | 34.8 |
| Staff buy-in, SPB | 56.5 |
| Staff buy-in, MPB | 8.6 |
| Storage/refrigeration, FPB | 34.8 |
| Storage/refrigeration, SPB | 43.5 |
| Storage/refrigeration, MPB | 21.7 |
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented.
| Participants | Participants With HIV Infection |
|---|---|
| Information and resources, EH | 50 |
| Information and resources, VH | 40 |
| Information and resources, SH | 4 |
| Information and resources, ALH | 2 |
| Information and resources, NAAH | 0 |
| Information and resources, DNR | 6 |
| Information and resources, RBDNU | 0 |
| Information and resources, Missing | 0 |
| Hot and cold pack, EH | 18 |
| Hot and cold pack, VH | 20 |
| Hot and cold pack, SH | 14 |
| Hot and cold pack, ALH | 6 |
| Hot and cold pack, NAAH | 8 |
| Hot and cold pack, DNR | 9 |
| Hot and cold pack, RBDNU | 27 |
| Hot and cold pack, Missing | 0 |
| Written materials, EH | 37 |
| Written materials, VH | 37 |
| Written materials, SH | 11 |
| Written materials, ALH | 2 |
| Written materials, NAAH | 0 |
| Written materials, DNR | 1 |
| Written materials, RBDNU | 14 |
| Written materials, Missing | 0 |
| Website for participants, EH | 25 |
| Website for participants, VH | 28 |
| Website for participants, SH | 11 |
| Website for participants, ALH | 2 |
| Website for participants, NAAH | 1 |
| Website for participants, DNR | 4 |
| Website for participants, RBDNU | 31 |
| Website for participants, Missing | 0 |
| Video, EH | 29 |
| Video, VH | 38 |
| Video, SH | 13 |
| Video, ALH | 5 |
| Video, NAAH | 1 |
| Video, DNR | 9 |
| Video, RBDNU | 6 |
| Video, Missing | 1 |
| Verbal information, EH | 69 |
| Verbal information, VH | 31 |
| Verbal information, SH | 2 |
| Verbal information, ALH | 0 |
| Verbal information, NAAH | 0 |
| Verbal information, DNR | 0 |
| Verbal information, RBDNU | 0 |
| Verbal information, Missing | 0 |
| Reminder calls, EH | 67 |
| Reminder calls, VH | 24 |
| Reminder calls, SH | 5 |
| Reminder calls, ALH | 1 |
| Reminder calls, NAAH | 1 |
| Reminder calls, DNR | 4 |
| Reminder calls, RBDNU | 0 |
| Reminder calls, Missing | 0 |
| Reminder text messages, EH | 63 |
| Reminder text messages, VH | 19 |
| Reminder text messages, SH | 4 |
| Reminder text messages, ALH | 1 |
| Reminder text messages, NAAH | 0 |
| Reminder text messages, DNR | 15 |
| Reminder text messages, RBDNU | 0 |
| Reminder text messages, Missing | 0 |
| Reminder app, EH | 26 |
| Reminder app, VH | 14 |
| Reminder app, SH | 3 |
| Reminder app, ALH | 0 |
| Reminder app, NAAH | 0 |
| Reminder app, DNR | 28 |
| Reminder app, RBDNU | 31 |
| Reminder app, Missing | 0 |
| Peer group informational (info) session, EH | 24 |
| Peer group info session, VH | 27 |
| Peer group info session, SH | 25 |
| Peer group info session, ALH | 6 |
| Peer group info session, NAAH | 20 |
| Peer group info session, DNR | NA |
| Peer group info session, RBDNU | NA |
| Peer group info session, Missing | 0 |
| Apts outside work time, EH | 63 |
| Apts outside work time, VH | 22 |
| Apts outside work time, SH | 13 |
| Apts outside work time, ALH | 1 |
| Apts outside work time, NAAH | 3 |
| Apts outside work time, DNR | NA |
| Apts outside work time, RBDNU | NA |
| Apts outside work time, Missing | 0 |
Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented.
| Participants | Participants With HIV Infection |
|---|---|
| Pain or soreness from the injection | 15 |
| Scheduling upcoming injection visits | 2 |
| Rescheduling missed injection visits | 1 |
| Forgetting appointment for the injection visits | 2 |
| Frequency of required visits to clinic for inj | 6 |
| Missing work too frequently for the injection | 7 |
| Transportation to clinic/practice for inj visit | 3 |
| Ease of parking at clinic/practice for inj visit | 4 |
| Limited clinic/practice hours for inj visits | 3 |
| Less privacy for inj visits than daily HIV medicine | 1 |
| Nothing is interfering with getting this treatment | 75 |
The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
| Barriers | Participants With HIV Infection |
|---|---|
| Facilitation call 1 | 5 |
| Facilitation call 2 | 3 |
| Facilitation call 3 | 7 |
| Facilitation call 4 | 6 |
| Facilitation call 5 | 4 |
| Facilitation call 6 | 7 |
| Facilitation call 7 | 3 |
The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
| Facilitators | Participants With HIV Infection |
|---|---|
| Facilitation call 1 | 7 |
| Facilitation call 2 | 3 |
| Facilitation call 3 | 3 |
| Facilitation call 4 | 5 |
| Facilitation call 5 | 9 |
| Facilitation call 6 | 9 |
| Facilitation call 7 | 8 |
The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
| Best practices | Participants With HIV Infection |
|---|---|
| Facilitation call 1 | 5 |
| Facilitation call 2 | 2 |
| Facilitation call 3 | 2 |
| Facilitation call 4 | 5 |
| Facilitation call 5 | 6 |
| Facilitation call 6 | 6 |
| Facilitation call 7 | 8 |
Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
| Participants | Staff Study Participants |
|---|---|
| Website for clinical staff, not used | 9 |
| Website for clinical staff, used similar | 1 |
| Website for clinical staff, used | 14 |
| Video on giving CAB + RPV LA injection, not used | 8 |
| Video on giving CAB + RPV LA injection, used similar | 1 |
| Video on giving CAB + RPV LA injection, used | 15 |
| How to use new packaging card, not used | 11 |
| How to use new packaging card, used similar | 0 |
| How to use new packaging card, used | 13 |
| Study factsheet for HCP, not used | 8 |
| Study factsheet for HCP, used similar | 1 |
| Study factsheet for HCP, used | 15 |
| Consultation aid, not used | 12 |
| Consultation aid, used similar | 1 |
| Consultation aid, used | 11 |
| Reminder, e-app, not used | 16 |
| Reminder e-app, used similar | 2 |
| Reminder e-app, used | 6 |
| Reminder SMS/text, not used | 15 |
| Reminder SMS/text, used similar | 4 |
| Reminder SMS/text, used | 5 |
| F2F training, not used | 8 |
| F2F training, used similar | 1 |
| F2F training, used | 15 |
| Facilitation group calls, not used | 4 |
| Facilitation group calls, used similar | 1 |
| Facilitation group calls, used | 19 |
| WB treatment planner, not used | 12 |
| WB treatment planner, used similar | 0 |
| WB treatment planner, used | 12 |
| WB health clinic capacity planning tool, not used | 20 |
| WB health clinic planning tool, used similar | 2 |
| WB health clinic capacity planning tool, used | 2 |
| Injection flashcard, not used | 10 |
| Injection flashcard, used similar | 2 |
| Injection flashcard, used | 12 |
| Website for participants, not used | 14 |
| Website for participants, used similar | 1 |
| Website for participants, used | 9 |
| What to expect factsheet, not used | 8 |
| What to expect factsheet, used similar | 1 |
| What to expect factsheet, used | 15 |
| Participant handbook, not used | 12 |
| Participant handbook, used similar | 0 |
| Participant handbook, used | 12 |
| FAQ chatbot, not used | 18 |
| FAQ chatbot, used similar | 0 |
| FAQ chatbot, used | 6 |
| Trial guide app, not used | 19 |
| Trail guide app, used similar | 0 |
| Trial guide app, used | 5 |
| Video-what to expect, not used | 8 |
| Video-what to expect, used similar | 0 |
| Video-what to expect, used | 16 |
| Hot and cold pack, not used | 6 |
| Hot and cold pack, used similar | 0 |
| Hot and cold pack, used | 18 |
Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
| Participants | Staff Study Participants |
|---|---|
| Website for clinical staff, not used | 13 |
| Website for clinical staff, used similar | 0 |
| Website for clinical staff, used | 10 |
| Video on giving CAB + RPV LA injection, not used | 6 |
| Video on giving CAB + RPV LA injection, used similar | 0 |
| Video on giving CAB + RPV LA injection, used | 17 |
| How to use new packaging card, not used | 14 |
| How to use new packaging card, used similar | 0 |
| How to use new packaging card, used | 9 |
| Study factsheet for HCP, not used | 10 |
| Study factsheet for HCP, used similar | 1 |
| Study factsheet for HCP, used | 12 |
| Consultation aid, not used | 14 |
| Consultation aid, used similar | 0 |
| Consultation aid, used | 9 |
| Reminder, e-app, not used | 15 |
| Reminder e-app, used similar | 6 |
| Reminder e-app, used | 2 |
| Reminder SMS/text, not used | 8 |
| Reminder SMS/text, used similar | 10 |
| Reminder SMS/text, used | 5 |
| F2F training, not used | 3 |
| F2F training, used similar | 1 |
| F2F training, used | 19 |
| Facilitation group calls, not used | 6 |
| Facilitation group calls, used similar | 1 |
| Facilitation group calls, used | 16 |
| WB treatment planner, not used | 11 |
| WB treatment planner, used similar | 2 |
| WB treatment planner, used | 10 |
| WB health clinic capacity planning tool, not used | 16 |
| WB health clinic planning tool, used similar | 4 |
| WB health clinic capacity planning tool, used | 3 |
| Injection flashcard, not used | 9 |
| Injection flashcard, used similar | 2 |
| Injection flashcard, used | 12 |
| Website for participants, not used | 15 |
| Website for participants, used similar | 2 |
| Website for participants, used | 6 |
| What to expect factsheet, not used | 5 |
| What to expect factsheet, used similar | 2 |
| What to expect factsheet, used | 16 |
| Participant handbook, not used | 8 |
| Participant handbook, used similar | 2 |
| Participant handbook, used | 13 |
| FAQ chatbot, not used | 18 |
| FAQ chatbot, used similar | 2 |
| FAQ chatbot, used | 3 |
| Trial guide app, not used | 20 |
| Trail guide app, used similar | 2 |
| Trial guide app, used | 1 |
| Video-what to expect, not used | 8 |
| Video-what to expect, used similar | 1 |
| Video-what to expect, used | 14 |
| Hot and cold pack, not used | 2 |
| Hot and cold pack, used similar | 0 |
| Hot and cold pack, used | 21 |
Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented.
| Percentage of participants | Participants With HIV Infection |
|---|---|
| Information and resources, EH | 49.5 |
| Information and resources, VH | 38.1 |
| Information and resources, SH | 6.7 |
| Information and resources, ALH | 1.9 |
| Information and resources, NAAH | 0.0 |
| Information and resources, DNR | 3.8 |
| Information and resources, RBDNU | 0.0 |
| Information and resources, Missing | 0.0 |
| Hot and cold pack, EH | 19.0 |
| Hot and cold pack, VH | 8.6 |
| Hot and cold pack, SH | 21.9 |
| Hot and cold pack, ALH | 8.6 |
| Hot and cold pack, NAAH | 2.9 |
| Hot and cold pack, DNR | 14.3 |
| Hot and cold pack, RBDNU | 23.8 |
| Hot and cold pack, Missing | 1.0 |
| Written materials, EH | 38.1 |
| Written materials, VH | 35.2 |
| Written materials, SH | 12.4 |
| Written materials, ALH | 1.9 |
| Written materials, NAAH | 1.0 |
| Written materials, DNR | 1.9 |
| Written materials, RBDNU | 9.5 |
| Written materials, Missing | 0.0 |
| Website, EH | 21.0 |
| Website, VH | 28.6 |
| Website, SH | 5.7 |
| Website, ALH | 1.9 |
| Website, NAAH | 1.9 |
| Website, DNR | 6.7 |
| Website, RBDNU | 34.3 |
| Website, Missing | 0.0 |
| Video, EH | 28.6 |
| Video, VH | 41.0 |
| Video, SH | 12.4 |
| Video, ALH | 4.8 |
| Video, NAAH | 1.9 |
| Video, DNR | 8.6 |
| Video, RBDNU | 2.9 |
| Video, Missing | 0.0 |
| Verbal information, EH | 62.9 |
| Verbal information, VH | 32.4 |
| Verbal information, SH | 3.8 |
| Verbal information, ALH | 0.0 |
| Verbal information, NAAH | 0.0 |
| Verbal information, DNR | 0.0 |
| Verbal information, RBDNU | 0.0 |
| Verbal information, Missing | 1.0 |
| Reminder calls, EH | 61.0 |
| Reminder calls, VH | 23.8 |
| Reminder calls, SH | 4.8 |
| Reminder calls, ALH | 4.8 |
| Reminder calls, NAAH | 0.0 |
| Reminder calls, DNR | 4.8 |
| Reminder calls, RBDNU | 0.0 |
| Reminder calls, Missing | 1.0 |
| Reminder text messages, EH | 56.2 |
| Reminder text messages, VH | 19.0 |
| Reminder text messages, SH | 4.8 |
| Reminder text messages, ALH | 1.0 |
| Reminder text messages, NAAH | 0.0 |
| Reminder text messages, DNR | 18.1 |
| Reminder text messages, RBDNU | 0.0 |
| Reminder text messages, Missing | 1.0 |
| Reminder app, EH | 23.8 |
| Reminder app, VH | 16.2 |
| Reminder app, SH | 2.9 |
| Reminder app, ALH | 1.9 |
| Reminder app, NAAH | 0.0 |
| Reminder app, DNR | 26.7 |
| Reminder app, RBDNU | 28.6 |
| Reminder app, Missing | 0.0 |
| Peer group informational (info) session, EH | 22.9 |
| Peer group info session, VH | 20.0 |
| Peer group info session, SH | 33.3 |
| Peer group info session, ALH | 8.6 |
| Peer group info session, NAAH | 14.3 |
| Peer group info session, DNR | NA |
| Peer group info session, RBDNU | NA |
| Peer group info session, Missing | 1.0 |
| Apts outside work time, EH | 57.1 |
| Apts outside work time, VH | 26.7 |
| Apts outside work time, SH | 6.7 |
| Apts outside work time, ALH | 4.8 |
| Apts outside work time, NAAH | 4.8 |
| Apts outside work time, DNR | NA |
| Apts outside work time, RBDNU | NA |
| Apts outside work time, Missing | 0.0 |
Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date.
| Participants | Participants With HIV Infection |
|---|---|
| Number of Participants Receiving Injections Within Target Window at Month 4 | 100 |
Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date.
| Participants | Participants With HIV Infection |
|---|---|
| Number of Participants Receiving Injections Within Target Window at Month 12 | 96 |
Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts)
| Scores on a scale | Staff Study Participants |
|---|---|
| Environmental support | 5.82 ± 0.20 |
| Organizational capacity | 5.74 ± 0.28 |
| Program evaluation | 5.83 ± 0.49 |
| Program adaptation | 5.98 ± 0.15 |
| Communications | 6.09 ± 0.06 |
| Strategic planning | 5.50 ± 0.34 |
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
| Scores on a scale | Participants With HIV Infection |
|---|---|
| HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1 | 60.7 ± 6.3 |
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
| Scores on a scale | Participants With HIV Infection |
|---|---|
| HIV-TSQs Scores at Month 4 | 62.12 ± 5.79 |
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
| Scores on a scale | Participants With HIV Infection |
|---|---|
| HIV-TSQs Scores at Month 12 | 63.30 ± 3.81 |
The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable.
| Participants | Participants With HIV Infection |
|---|---|
| Extremely acceptable | 62 |
| Very acceptable | 33 |
| Somewhat acceptable | 7 |
| A little acceptable | 0 |
| Not at all acceptable | 0 |
Number of participants with the reported time spent in clinic/practice for each injection visit is presented.
| Participants | Participants With HIV Infection |
|---|---|
| 1-15 minutes | 14 |
| 16-30 minutes | 51 |
| 31-45 minutes | 23 |
| 46-60 minutes | 12 |
| More than 60 minutes | 1 |
Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable.
| Participants | Participants With HIV Infection |
|---|---|
| Extremely knowledgeable | 34 |
| Very knowledgeable | 40 |
| Somewhat knowledgeable | 25 |
| A little knowledgeable | 2 |
| Not at all knowledgeable | 1 |
Length of visit was calculated by subtracting the arrival time (Lead time \[actual start time of appointment - arrival time\] + process time \[actual end time of appointment - actual start time of appointment\]) from actual end time of appointment.
| Minutes | Participants With HIV Infection |
|---|---|
| At Month 1, n=109 | 63.4 ± 29.51 |
| At Month 5, n=104 | 38.7 ± 19.91 |
| At Month 11, n=100 | 36.3 ± 16.85 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach.
| Percentage of participants | Participants With HIV Infection |
|---|---|
| Month 1 | 93.9 |
| Month 2 | 94.8 |
| Month 4 | 91.3 |
| Month 6 | 90.4 |
| Month 8 | 88.7 |
| Month 10 | 87.8 |
| Month 12 | 88.7 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage value presented has been rounded off.
| Percentage of participants | Participants With HIV Infection |
|---|---|
| Month 1; n=112 | 96 |
| Month 2; n=109 | 100 |
| Month 4; n=107 | 98 |
| Month 6; n=103 | 100 |
| Month 8; n=94 | 100 |
| Month 10; n=100 | 99 |
| Month 12, n=101 | 100 |
| Month 13; n=101 | 100 |
| Month 15; n=99 | 100 |
| Month 16; n=94 | 99 |
| Month 18; n=95 | 100 |
| Month 19; n=89 | 100 |
| Month 21; n=75 | 100 |
| Month 22; n=61 | 100 |
| Month 24; n=35 | 100 |
| Month 25; n=17 | 100 |
| Month 27; n=8 | 100 |
| Month 28; n=7 | 100 |
| Month 30; n=1 | 100 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (\>=)200 copies/mL after prior suppression to \<200 copies/mL.
| Percentage of participants | Participants With HIV Infection |
|---|---|
| Percentage of Participants With Confirmed Virologic Failure (CVF) | 0 |
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent genotypic resistance is summarized.
No measurements were reported for this outcome.
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent phenotypic resistance is summarized.
No measurements were reported for this outcome.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (\>=5%) non-SAEs are presented. Adverse events which were not serious have been considered as non-serious adverse events.
| Participants | Participants With HIV Infection |
|---|---|
| Common (>=5%) non-SAEs | 101 |
| SAEs | 9 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off.
| Percentage of participants | Participants With HIV Infection |
|---|---|
| Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time | 7 |
Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
| Participants | Participants With HIV Infection |
|---|---|
| Leukocytes, increase from Grade 1 to 4 | 5 |
| Leukocytes, increase from Grade 2 to 4 | 2 |
| Leukocytes, increase from Grade 3 to 4 | 1 |
| Neutrophils, increase from Grade 1 to 4 | 8 |
| Neutrophils, increase from Grade 2 to 4 | 3 |
| Neutrophils, increase from Grade 3 to 4 | 1 |
| Platelets, increase from Grade 1 to 4 | 1 |
| Platelets, increase from Grade 2 to 4 | 0 |
| Platelets, increase from Grade 3 to 4 | 0 |
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. The parameters were graded according to the DAIDS toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
| Participants | Participants With HIV Infection |
|---|---|
| Hemoglobin, increase from Grades 1 to 4 | 1 |
| Hemoglobin, increase from Grades 2 to 4 | 0 |
| Hemoglobin, increase from Grades 3 to 4 | 0 |
| Leukocytes, increase from Grade 1 to 4 | 6 |
| Leukocytes, increase from Grade 2 to 4 | 2 |
| Leukocytes, increase from Grade 3 to 4 | 1 |
| Neutrophils, increase from Grade 1 to 4 | 9 |
| Neutrophils, increase from Grade 2 to 4 | 4 |
| Neutrophils, increase from Grade 3 to 4 | 2 |
| Platelets, increase from Grade 1 to 4 | 2 |
| Platelets, increase from Grade 2 to 4 | 0 |
| Platelets, increase from Grade 3 to 4 | 0 |
Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
| Participants | Participants With HIV Infection |
|---|---|
| ALT, increase from Grade 1 to 4 | 15 |
| ALT, increase from Grade 2 to 4 | 3 |
| ALT, increase from Grade 3 to 4 | 0 |
| ALP, increase from Grade 1 to 4 | 3 |
| ALP, increase from Grade 2 to 4 | 0 |
| ALP, increase from Grade 3 to 4 | 0 |
| AST, increase from Grade 1 to 4 | 8 |
| AST, increase from Grade 2 to 4 | 4 |
| AST, increase from Grade 3 to 4 | 0 |
| Bilirubin, increase from Grade 1 to 4 | 4 |
| Bilirubin, increase from Grade 2 to 4 | 1 |
| Bilirubin, increase from Grade 3 to 4 | 0 |
| CO2, increase from Grade 1 to 4 | 16 |
| CO2, increase from Grade 2 to 4 | 0 |
| CO2, increase from Grade 3 to 4 | 0 |
| CK, increase from Grade 1 to 4 | 11 |
| CK, increase from Grade 2 to 4 | 4 |
| CK, increase from Grade 3 to 4 | 1 |
| Creatinine, increase from Grade 1 to 4 | 2 |
| Creatinine, increase from Grade 2 to 4 | 1 |
| Creatinine, increase from Grade 3 to 4 | 0 |
| Direct bilirubin, increase from Grade 1 to 4 | 1 |
| Direct bilirubin, increase from Grade 2 to 4 | 1 |
| Direct bilirubin, increase from Grade 3 to 4 | 1 |
| Glucose, increase from Grade 1 to 4 | 18 |
| Glucose, increase from Grade 2 to 4 | 8 |
| Glucose, increase from Grade 3 to 4 | 0 |
| Lipase, increase from Grade 1 to 4 | 17 |
| Lipase, increase from Grade 2 to 4 | 11 |
| Lipase, increase from Grade 3 to 4 | 0 |
| Phosphate, increase from Grade 1 to 4 | 16 |
| Phosphate, increase from Grade 2 to 4 | 4 |
| Phosphate, increase from Grade 3 to 4 | 0 |
| Potassium, increase from Grade 1 to 4 | 4 |
| Potassium, increase from Grade 2 to 4 | 0 |
| Potassium, increase from Grade 3 to 4 | 0 |
| Sodium, increase from Grade 1 to 4 | 6 |
| Sodium, increase from Grade 2 to 4 | 0 |
| Sodium, increase from Grade 3 to 4 | 0 |
Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST, bilirubin, CO2, CK, creatinine, direct bilirubin, Glomerular filtration rate (GFR) from Creatinine (Creat) Adjusted (Adj) using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), GFR From Creat Adj for body surface area (BSA), glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
| Participants | Participants With HIV Infection |
|---|---|
| ALT, increase from Grade 1 to 4 | 24 |
| ALT, increase from Grade 2 to 4 | 6 |
| ALT, increase from Grade 3 to 4 | 0 |
| ALP, increase from Grade 1 to 4 | 3 |
| ALP, increase from Grade 2 to 4 | 0 |
| ALP, increase from Grade 3 to 4 | 0 |
| AST, increase from Grade 1 to 4 | 13 |
| AST, increase from Grade 2 to 4 | 5 |
| AST, increase from Grade 3 to 4 | 1 |
| Bilirubin, increase from Grade 1 to 4 | 6 |
| Bilirubin, increase from Grade 2 to 4 | 1 |
| Bilirubin, increase from Grade 3 to 4 | 0 |
| CO2, increase from Grade 1 to 4 | 18 |
| CO2, increase from Grade 2 to 4 | 0 |
| CO2, increase from Grade 3 to 4 | 0 |
| CK, increase from Grade 1 to 4 | 18 |
| CK, increase from Grade 2 to 4 | 9 |
| CK, increase from Grade 3 to 4 | 4 |
| Creatinine, increase from Grade 1 to 4 | 5 |
| Creatinine, increase from Grade 2 to 4 | 1 |
| Creatinine, increase from Grade 3 to 4 | 0 |
| Direct bilirubin, increase from Grade 1 to 4 | 1 |
| Direct bilirubin, increase from Grade 2 to 4 | 1 |
| Direct bilirubin, increase from Grade 3 to 4 | 1 |
| GFR From Creat Adj Using CKD-EPI increase from Grade 1 to 4 | 27 |
| GFR From Creat Adj Using CKD-EPI increase from Grade 2 to 4 | 27 |
| GFR From Creat Adj Using CKD-EPI increase from Grade 3 to 4 | 6 |
| GFR From Creat Adj for BSA increase from Grade 1 to 4 | 27 |
| GFR From Creat Adj for BSA increase from Grade 2 to 4 | 27 |
| GFR From Creat Adj for BSA increase from Grade 3 to 4 | 6 |
| Glucose, increase from Grade 1 to 4 | 26 |
| Glucose, increase from Grade 2 to 4 | 16 |
| Glucose, increase from Grade 3 to 4 | 2 |
| Lipase, increase from Grade 1 to 4 | 23 |
| Lipase, increase from Grade 2 to 4 | 16 |
| Lipase, increase from Grade 3 to 4 | 0 |
| Phosphate, increase from Grade 1 to 4 | 22 |
| Phosphate, increase from Grade 2 to 4 | 6 |
| Phosphate, increase from Grade 3 to 4 | 0 |
| Potassium, increase from Grade 1 to 4 | 4 |
| Potassium, increase from Grade 2 to 4 | 0 |
| Potassium, increase from Grade 3 to 4 | 0 |
| Sodium, increase from Grade 1 to 4 | 7 |
| Sodium, increase from Grade 2 to 4 | 0 |
| Sodium, increase from Grade 3 to 4 | 0 |
Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
| Participants | Participants With HIV Infection |
|---|---|
| Number of Participants With Urinalysis Result of Potential Clinical Importance | 8 |
Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
| Participants | Participants With HIV Infection |
|---|---|
| Number of Participants With Urinalysis Result of Potential Clinical Importance Through End of Study | 1 |
Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
| Participants | Participants With HIV Infection |
|---|---|
| Month 1 | 109 |
| Month 2 | 108 |
| Month 3 | 106 |
| Month 4 | 105 |
| Month 5 | 104 |
| Month 6 | 103 |
| Month 7 | 103 |
| Month 8 | 102 |
| Month 9 | 100 |
| Month 10 | 100 |
| Month 11 | 100 |
| Month 12 | 101 |
Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
| Participants | Participants With HIV Infection |
|---|---|
| Month 13 | 99 |
| Month 14 | 99 |
| Month 15 | 98 |
| Month 16 | 96 |
| Month 17 | 95 |
| Month 18 | 97 |
| Month 19 | 95 |
| Month 20 | 86 |
| Month 21 | 75 |
| Month 22 | 65 |
| Month 23 | 49 |
| Month 24 | 35 |
| Month 25 | 19 |
| Month 26 | 11 |
| Month 27 | 8 |
| Month 28 | 7 |
| Month 29 | 4 |
| Month 30 | 1 |
Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| 10^9 cells per Liter | Participants With HIV Infection |
|---|---|
| Platelet count, n=100 | -0.66 ± 33.512 |
| WBC count, n=101 | 0.27 ± 1.412 |
| Basophil count, n=101 | 0.006 ± 0.0232 |
| Eosinophil count, n=101 | 0.018 ± 0.1632 |
| Lymphocyte count, n=101 | -0.0005 ± 0.49237 |
| Monocyte count, n=101 | 0.029 ± 0.1434 |
| Neutrophil count, n=101 | 0.214 ± 1.1746 |
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| 10^12 cells per liter | Participants With HIV Infection |
|---|---|
| Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count | 0.18 ± 0.260 |
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Grams per liter | Participants With HIV Infection |
|---|---|
| Change From Baseline in Hematology Parameter: Hemoglobin | -1.11 ± 7.221 |
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Percentage of red blood cells in blood | Participants With HIV Infection |
|---|---|
| Change From Baseline in Hematology Parameter: Hematocrit | -0.0022 ± 0.02554 |
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Femtoliter | Participants With HIV Infection |
|---|---|
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV) | -3.90 ± 2.961 |
Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| 10^9 cells per Liter | Participants With HIV Infection |
|---|---|
| Platelet count, Month 15, n=98 | 5.47 ± 41.191 |
| Platelet count, Month 18, n=96 | 9.59 ± 57.934 |
| Platelet count, Month 21, n=75 | 8.07 ± 34.613 |
| Platelet count, Month 24, n=35 | 14.51 ± 24.923 |
| Platelet count, Month 27, n=8 | 31.13 ± 48.265 |
| Platelet count, Month 30, n=1 | 73.00 ± NA |
| WBC count, Month 15, n=99 | 0.66 ± 1.648 |
| WBC count, Month 18, n=97 | 0.23 ± 1.718 |
| WBC count, Month 21, n=75 | 0.30 ± 1.452 |
| WBC count, Month 24, n=35 | -0.04 ± 1.463 |
| WBC count, Month 27, n=8 | -0.05 ± 1.543 |
| WBC count, Month 30, n=1 | 0.40 ± NA |
| Basophil count, Month 15, n=99 | 0.009 ± 0.0292 |
| Basophil count, Month 18, n=97 | 0.008 ± 0.0374 |
| Basophil count, Month 21, n=75 | 0.001 ± 0.0243 |
| Basophil count, Month 24, n=35 | -0.002 ± 0.0268 |
| Basophil count, Month 27, n=8 | 0.010 ± 0.0351 |
| Basophil count, Month 30, n=1 | 0.060 ± NA |
| Eosinophil count, Month 15, n=99 | 0.019 ± 0.1623 |
| Eosinophil count, Month 18, n=97 | 0.008 ± 0.1609 |
| Eosinophil count, Month 21, n=75 | -0.001 ± 0.1683 |
| Eosinophil count, Month 24, n=35 | -0.033 ± 0.2489 |
| Eosinophil count, Month 27, n=8 | -0.060 ± 0.0650 |
| Eosinophil count, Month 30, n=1 | 0.010 ± NA |
| Lymphocyte count, Month 15, n=99 | 0.1654 ± 0.53448 |
| Lymphocyte count, Month 18, n=97 | 0.1315 ± 0.71555 |
| Lymphocyte count, Month 21, n=75 | 0.0360 ± 0.51313 |
| Lymphocyte count, Month 24, n=35 | -0.1046 ± 0.50251 |
| Lymphocyte count, Month 27, n=8 | 0.0237 ± 0.47192 |
| Lymphocyte count, Month 30, n=1 | -0.2100 ± NA |
| Monocyte count, Month 15, n=99 | 0.091 ± 0.1707 |
| Monocyte count, Month 18, n=97 | 0.085 ± 0.2257 |
| Monocyte count, Month 21, n=75 | 0.048 ± 0.1280 |
| Monocyte count, Month 24, n=35 | -0.009 ± 0.1228 |
| Monocyte count, Month 27, n=8 | -0.030 ± 0.1743 |
| Monocyte count, Month 30, n=1 | 0.110 ± NA |
| Neutrophil count, Month 15, n=99 | 0.365 ± 1.3448 |
| Neutrophil count, Month 18, n=97 | -0.007 ± 1.2956 |
| Neutrophil count, Month 21, n=75 | 0.211 ± 1.2534 |
| Neutrophil count, Month 24, n=35 | 0.109 ± 1.2653 |
| Neutrophil count, Month 27, n=8 | -0.003 ± 1.0602 |
| Neutrophil count, Month 30, n=1 | 0.350 ± NA |
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| 10^12 cells per liter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 0.17 ± 0.245 |
| Month 18, n=97 | 0.19 ± 0.313 |
| Month 21, n=75 | 0.19 ± 0.248 |
| Month 24, n=35 | 0.16 ± 0.274 |
| Month 27, n=8 | 0.14 ± 0.267 |
| Month 30, n=1 | 0.10 ± NA |
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Grams per liter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | -0.71 ± 7.172 |
| Month 18, n=97 | -0.29 ± 9.920 |
| Month 21, n=75 | -1.09 ± 6.717 |
| Month 24, n=35 | -2.26 ± 7.636 |
| Month 27, n=8 | -3.25 ± 5.203 |
| Month 30, n=1 | -4.00 ± NA |
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Percentage of red blood cells in blood | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | -0.0133 ± 0.02272 |
| Month 18, n=97 | -0.0134 ± 0.02963 |
| Month 21, n=75 | -0.0091 ± 0.02346 |
| Month 24, n=35 | -0.0102 ± 0.02364 |
| Month 27, n=8 | -0.0166 ± 0.01935 |
| Month 30, n=1 | -0.0340 ± NA |
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Femtoliter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | -6.13 ± 2.724 |
| Month 18, n=97 | -6.64 ± 3.004 |
| Month 21, n=75 | -5.61 ± 3.413 |
| Month 24, n=35 | -5.37 ± 2.691 |
| Month 27, n=8 | -6.25 ± 3.770 |
| Month 30, n=1 | -7.00 ± NA |
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count.
| 10^9 cells per liter | Participants With HIV Infection |
|---|---|
| Platelet count, n=100 | 238.78 ± 56.321 |
| WBC count, n=101 | 5.81 ± 1.606 |
| Basophil count, n=101 | 0.042 ± 0.0239 |
| Eosinophil count, n=101 | 0.160 ± 0.1305 |
| Lymphocyte count, n=101 | 1.9528 ± 0.58037 |
| Monocyte count, n=101 | 0.388 ± 0.1352 |
| Neutrophil count, n=101 | 3.269 ± 1.3055 |
Blood samples were collected to analyze the hematology parameter: RBC count.
| 10^12 cells per liter | Participants With HIV Infection |
|---|---|
| Absolute Values of Hematology Parameter: RBC Count | 4.84 ± 0.504 |
Blood samples were collected to analyze the hematology parameter: Hemoglobin
| Grams per liter | Participants With HIV Infection |
|---|---|
| Absolute Values of Hematology Parameter: Hemoglobin | 145.19 ± 11.121 |
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1)
| Percentage of red blood cells in blood | Participants With HIV Infection |
|---|---|
| Absolute Values of Hematology Parameter: Hematocrit | 0.4445 ± 0.03412 |
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
| Femtoliter | Participants With HIV Infection |
|---|---|
| Absolute Values of Hematology Parameter: Erythrocytes MCV | 92.37 ± 5.546 |
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count.
| 10^9 cells per Liter | Participants With HIV Infection |
|---|---|
| Platelet count, Month 15, n=99 | 245.56 ± 62.285 |
| Platelet count, Month 18, n=97 | 250.99 ± 68.610 |
| Platelet count, Month 21, n=75 | 247.04 ± 50.792 |
| Platelet count, Month 24, n=35 | 245.43 ± 54.199 |
| Platelet count, Month 27, n=8 | 271.63 ± 81.512 |
| Platelet count, Month 30, n=1 | 417.00 ± NA |
| WBC count, Month 15, n=99 | 6.21 ± 1.983 |
| WBC count, Month 18, n=97 | 5.79 ± 1.748 |
| WBC count, Month 21, n=75 | 5.92 ± 1.626 |
| WBC count, Month 24, n=35 | 5.75 ± 1.377 |
| WBC count, Month 27, n=8 | 6.55 ± 1.787 |
| WBC count, Month 30, n=1 | 12.30 ± NA |
| Basophil count, Month 15, n=99 | 0.045 ± 0.0255 |
| Basophil count, Month 18, n=97 | 0.044 ± 0.0344 |
| Basophil count, Month 21, n=75 | 0.037 ± 0.0222 |
| Basophil count, Month 24, n=35 | 0.033 ± 0.0214 |
| Basophil count, Month 27, n=8 | 0.039 ± 0.0210 |
| Basophil count, Month 30, n=1 | 0.090 ± NA |
| Eosinophil count, Month 15, n=99 | 0.163 ± 0.1238 |
| Eosinophil count, Month 18, n=97 | 0.151 ± 0.1052 |
| Eosinophil count, Month 21, n=75 | 0.141 ± 0.1085 |
| Eosinophil count, Month 24, n=35 | 0.143 ± 0.1366 |
| Eosinophil count, Month 27, n=8 | 0.090 ± 0.0366 |
| Eosinophil count, Month 30, n=1 | 0.090 ± NA |
| Lymphocyte count, Month 15, n=99 | 2.1271 ± 0.61543 |
| Lymphocyte count, Month 18, n=97 | 2.0999 ± 0.74371 |
| Lymphocyte count, Month 21, n=75 | 2.0521 ± 0.58855 |
| Lymphocyte count, Month 24, n=35 | 1.9229 ± 0.53307 |
| Lymphocyte count, Month 27, n=8 | 2.1350 ± 0.63370 |
| Lymphocyte count, Month 30, n=1 | 1.9100 ± NA |
| Monocyte count, Month 15, n=99 | 0.451 ± 0.1617 |
| Monocyte count, Month 18, n=97 | 0.444 ± 0.2301 |
| Monocyte count, Month 21, n=75 | 0.423 ± 0.1379 |
| Monocyte count, Month 24, n=35 | 0.388 ± 0.0859 |
| Monocyte count, Month 27, n=8 | 0.396 ± 0.1640 |
| Monocyte count, Month 30, n=1 | 0.540 ± NA |
| Neutrophil count, Month 15, n=99 | 3.423 ± 1.6355 |
| Neutrophil count, Month 18, n=97 | 3.056 ± 1.3502 |
| Neutrophil count, Month 21, n=75 | 3.275 ± 1.2803 |
| Neutrophil count, Month 24, n=35 | 3.273 ± 1.1311 |
| Neutrophil count, Month 27, n=8 | 3.906 ± 1.6430 |
| Neutrophil count, Month 30, n=1 | 9.640 ± NA |
Blood samples were collected to analyze the hematology parameter: RBC count.
| 10^12 cells per liter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 4.85 ± 0.482 |
| Month 18, n=97 | 4.85 ± 0.534 |
| Month 21, n=75 | 4.84 ± 0.474 |
| Month 24, n=35 | 4.90 ± 0.513 |
| Month 27, n=8 | 4.88 ± 0.557 |
| Month 30, n=1 | 5.10 ± NA |
Blood samples were collected to analyze the hematology parameter: Hemoglobin.
| Grams per liter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 145.84 ± 10.827 |
| Month 18, n=97 | 146.08 ± 14.021 |
| Month 21, n=75 | 144.52 ± 11.781 |
| Month 24, n=35 | 144.46 ± 11.559 |
| Month 27, n=8 | 138.25 ± 18.344 |
| Month 30, n=1 | 130.00 ± NA |
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1).
| Percentage of red blood cells in blood | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 0.4341 ± 0.03251 |
| Month 18, n=97 | 0.4335 ± 0.04229 |
| Month 21, n=75 | 0.4349 ± 0.03472 |
| Month 24, n=35 | 0.4377 ± 0.03484 |
| Month 27, n=8 | 0.4183 ± 0.05263 |
| Month 30, n=1 | 0.3960 ± NA |
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
| Femtoliter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 90.16 ± 5.138 |
| Month 18, n=97 | 89.64 ± 5.048 |
| Month 21, n=75 | 90.39 ± 5.533 |
| Month 24, n=35 | 89.74 ± 5.468 |
| Month 27, n=8 | 85.75 ± 4.652 |
| Month 30, n=1 | 78.00 ± NA |
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Millimoles per liter | Participants With HIV Infection |
|---|---|
| Sodium | 0.2 ± 2.00 |
| Potassium | 0.02 ± 0.295 |
| Carbon dioxide | -0.0 ± 2.20 |
| Chloride | -0.8 ± 2.34 |
| Glucose | -0.37 ± 1.636 |
| Urea | 0.13 ± 1.324 |
| Phosphate | -0.005 ± 0.1853 |
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Micromoles per liter | Participants With HIV Infection |
|---|---|
| Creatinine | -1.59 ± 14.736 |
| Bilirubin | 0.9 ± 4.24 |
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| International units per liter | Participants With HIV Infection |
|---|---|
| ALT | 1.1 ± 14.17 |
| AST | 0.5 ± 11.59 |
| ALP | 0.3 ± 12.27 |
| Creatine kinase | -29.1 ± 278.65 |
Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Milliliters/seconds/1.73 meter square | Participants With HIV Infection |
|---|---|
| Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | 0.00520 ± 0.221404 |
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Units per liter | Participants With HIV Infection |
|---|---|
| Change From Baseline in Clinical Laboratory Parameter: Lipase | -2.3 ± 21.54 |
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Grams per liter | Participants With HIV Infection |
|---|---|
| Change From Baseline in Clinical Laboratory Parameter: Albumin | 0.2 ± 2.54 |
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Millimoles per liter | Participants With HIV Infection |
|---|---|
| Sodium, Month 15, n=99 | -0.2 ± 1.93 |
| Sodium, Month 18, n=97 | -0.2 ± 1.78 |
| Sodium, Month 21, n=75 | -0.6 ± 1.97 |
| Sodium, Month 24, n=35 | -0.9 ± 2.39 |
| Sodium, Month 27, n=8 | -1.1 ± 2.03 |
| Sodium, Month 30, n=1 | -2.0 ± NA |
| Potassium, Month 15, n=99 | 0.02 ± 0.325 |
| Potassium, Month 18, n=97 | 0.03 ± 0.315 |
| Potassium, Month 21, n=75 | -0.05 ± 0.321 |
| Potassium, Month 24, n=35 | -0.10 ± 0.335 |
| Potassium, Month 27, n=8 | -0.13 ± 0.271 |
| Potassium, Month 30,n=1 | 0.40 ± NA |
| Carbon dioxide, Month 15, n=99 | 0.7 ± 2.10 |
| Carbon dioxide, Month 18, n=97 | 1.0 ± 2.26 |
| Carbon dioxide, Month 21, n=75 | 0.6 ± 1.86 |
| Carbon dioxide, Month 24, n=35 | 0.3 ± 2.09 |
| Carbon dioxide, Month 27, n=8 | 0.4 ± 2.72 |
| Carbon dioxide, Month 30, n=1 | 2.0 ± NA |
| Chloride, Month 15, n=99 | -1.5 ± 2.29 |
| Chloride, Month 18, n=97 | -1.6 ± 2.31 |
| Chloride, Month 21, n=75 | -2.2 ± 2.30 |
| Chloride, Month 24, n=35 | -1.8 ± 2.21 |
| Chloride, Month 27, n=8 | -1.3 ± 1.58 |
| Chloride, Month 30, n=1 | -3.0 ± NA |
| Glucose, Month 15, n=99 | 0.05 ± 1.907 |
| Glucose, Month 18, n=97 | 0.22 ± 2.804 |
| Glucose, Month 21, n=75 | 0.24 ± 2.033 |
| Glucose, Month 24, n=35 | 0.42 ± 2.546 |
| Glucose, Month 27, n=8 | -0.30 ± 1.278 |
| Glucose, Month 30, n=1 | -0.30 ± NA |
| Urea; Month 15, n=99 | -0.15 ± 1.157 |
| Urea; Month 18, n=97 | 0.04 ± 1.364 |
| Urea; Month 21, n=75 | -0.06 ± 1.271 |
| Urea; Month 24, n=35 | 0.04 ± 1.114 |
| Urea; Month 27 , n=8 | 0.63 ± 1.458 |
| Urea; Month 30, n=1 | 1.00 ± NA |
| Phosphate; Month 15, n=99 | 0.006 ± 0.2069 |
| Phosphate; Month 18, n=97 | -0.007 ± 0.2015 |
| Phosphate; Month 21, n=75 | 0.001 ± 0.1940 |
| Phosphate; Month 24, n=35 | -0.009 ± 0.2248 |
| Phosphate; Month 27, n=8 | 0.031 ± 0.2120 |
| Phosphate; Month 30, n=1 | 0.350 ± NA |
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Micromoles per liter | Participants With HIV Infection |
|---|---|
| Creatinine, Month 15, n=99 | -2.73 ± 13.479 |
| Creatinine, Month 18, n=97 | 3.19 ± 12.588 |
| Creatinine, Month 21, n=75 | -2.92 ± 14.496 |
| Creatinine, Month 24, n=35 | -6.80 ± 16.452 |
| Creatinine, Month 27, n=8 | -6.95 ± 9.095 |
| Creatinine, Month 30, n=1 | -10.60 ± NA |
| Bilirubin, Month 15, n=99 | 0.7 ± 4.99 |
| Bilirubin, Month 18, n=97 | 0.4 ± 4.42 |
| Bilirubin, Month 21 n=75 | 1.7 ± 4.34 |
| Bilirubin, Month 24, n=35 | 1.9 ± 5.75 |
| Bilirubin, Month 27 n=8 | 0.8 ± 1.04 |
| Bilirubin, Month 30, n=1 | -4.0 ± NA |
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| International units per liter | Participants With HIV Infection |
|---|---|
| ALT, Month 15, n=99 | 4.0 ± 20.92 |
| ALT, Month 18, n=97 | 2.9 ± 14.96 |
| ALT, Month 21, n=75 | 3.1 ± 23.81 |
| ALT, Month 24, n=35 | -0.2 ± 12.35 |
| ALT, Month 27, n=8 | 1.6 ± 16.16 |
| ALT, Month 30 n=1 | -2.0 ± NA |
| ALP, Month 15, n=99 | -2.1 ± 13.62 |
| ALP, Month 18, n=97 | -0.8 ± 14.45 |
| ALP, Month 21, n=75 | -0.2 ± 13.61 |
| ALP, Month 24, n=35 | 0.1 ± 10.35 |
| ALP, Month 27, n=8 | 5.5 ± 12.32 |
| ALP, Month 30, n=1 | -9.0 ± NA |
| AST, Month 15, n=99 | 1.2 ± 9.63 |
| AST, Month 18, n=97 | 4.1 ± 26.52 |
| AST, Month 21, n=75 | 1.4 ± 8.80 |
| AST, Month 24, n=35 | -0.5 ± 5.54 |
| AST, Month 27, n=8 | 1.6 ± 9.65 |
| AST, Month 30, n=1 | -1.0 ± NA |
| Creatine Kinase, Month 15, n=99 | -25.0 ± 306.57 |
| Creatine Kinase, Month 18, n=97 | 132.5 ± 1053.02 |
| Creatine Kinase, Month 21, n=75 | 28.0 ± 454.78 |
| Creatine Kinase, Month 24, n=35 | -61.7 ± 376.27 |
| Creatine Kinase, Month 27, n=8 | 70.8 ± 107.32 |
| Creatine Kinase, Month 30, n=1 | -8.0 ± NA |
Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
| Milliliters/seconds/1.73 meter square | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 0.03216 ± 0.210193 |
| Month 18, n=93 | -0.09140 ± 0.190551 |
| Month 21, n=75 | 0.02044 ± 0.203936 |
| Month 24, n=35 | 0.07667 ± 0.252677 |
| Month 27, n=7 | 0.06905 ± 0.173056 |
| Month 30, n=1 | 0.20000 ± NA |
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Units per liter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 2.2 ± 32.47 |
| Month 18, n=93 | 0.9 ± 31.03 |
| Month 21, n=75 | -1.3 ± 29.74 |
| Month 24, n=35 | -9.9 ± 53.42 |
| Month 27, n=8 | 5.9 ± 23.43 |
| Month 30, n=1 | 2.0 ± NA |
Blood samples were collected for the analysis of clinical chemistry parameter-Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Grams per liter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | -0.0 ± 2.63 |
| Month 18, n=97 | -0.2 ± 2.75 |
| Month 21, n=75 | -0.3 ± 2.16 |
| Month 24, n=35 | -0.5 ± 2.09 |
| Month 27, n=8 | 0.0 ± 1.85 |
| Month 30, n=1 | 0.0 ± NA |
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
| Millimoles per liter | Participants With HIV Infection |
|---|---|
| Sodium | 139.7 ± 1.67 |
| Potassium | 4.15 ± 0.309 |
| Carbon dioxide | 23.1 ± 2.02 |
| Chloride | 103.8 ± 2.18 |
| Glucose | 5.26 ± 1.425 |
| Urea | 5.08 ± 1.588 |
| Phosphate | 1.087 ± 0.1687 |
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
| Micromoles per liter | Participants With HIV Infection |
|---|---|
| Creatinine | 89.10 ± 15.229 |
| Bilirubin | 10.0 ± 5.10 |
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
| International units per liter | Participants With HIV Infection |
|---|---|
| ALT | 24.6 ± 17.52 |
| AST | 21.7 ± 14.31 |
| ALP | 69.0 ± 19.42 |
| Creatine kinase | 181.4 ± 153.58 |
Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA
| Milliliters/seconds/1.73 meter square | Participants With HIV Infection |
|---|---|
| Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | 1.60853 ± 0.305979 |
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase.
| Units per liter | Participants With HIV Infection |
|---|---|
| Absolute Values of Clinical Laboratory Parameter: Lipase | 31.6 ± 25.92 |
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin.
| Grams per liter | Participants With HIV Infection |
|---|---|
| Absolute Values of Clinical Laboratory Parameter: Albumin | 44.7 ± 2.74 |
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
| Millimoles per liter | Participants With HIV Infection |
|---|---|
| Sodium, Month 15, n=99 | 139.3 ± 1.81 |
| Sodium, Month 18, n=97 | 139.3 ± 1.92 |
| Sodium, Month 21, n=75 | 139.0 ± 1.89 |
| Sodium, Month 24, n=35 | 138.7 ± 1.87 |
| Sodium, Month 27, n=8 | 138.1 ± 1.36 |
| Sodium, Month 30, n=1 | 137.0 ± NA |
| Potassium, Month 15, n=99 | 4.15 ± 0.366 |
| Potassium, Month 18, n=97 | 4.16 ± 0.340 |
| Potassium, Month 21, n=75 | 4.08 ± 0.313 |
| Potassium, Month 24, n=35 | 4.02 ± 0.308 |
| Potassium, Month 27, n=8 | 3.94 ± 0.119 |
| Potassium, Month 30,n=1 | 4.10 ± NA |
| Carbon dioxide, Month 15, n=99 | 23.8 ± 2.18 |
| Carbon dioxide, Month 18, n=97 | 24.1 ± 2.11 |
| Carbon dioxide, Month 21, n=75 | 23.8 ± 2.24 |
| Carbon dioxide, Month 24, n=35 | 23.8 ± 2.09 |
| Carbon dioxide, Month 27, n=8 | 23.5 ± 2.27 |
| Carbon dioxide, Month 30, n=1 | 24.0 ± NA |
| Chloride, Month 15, n=99 | 103.1 ± 2.29 |
| Chloride, Month 18, n=97 | 103.0 ± 2.37 |
| Chloride, Month 21, n=75 | 102.6 ± 2.24 |
| Chloride, Month 24, n=35 | 102.9 ± 2.18 |
| Chloride, Month 27, n=8 | 103.0 ± 1.85 |
| Chloride, Month 30, n=1 | 101.0 ± NA |
| Glucose, Month 15, n=99 | 5.72 ± 2.344 |
| Glucose, Month 18, n=97 | 5.89 ± 3.089 |
| Glucose, Month 21, n=75 | 5.86 ± 2.382 |
| Glucose, Month 24, n=35 | 6.14 ± 3.294 |
| Glucose, Month 27, n=8 | 5.33 ± 0.654 |
| Glucose, Month 30, n=1 | 4.40 ± NA |
| Urea; Month 15, n=99 | 4.81 ± 1.362 |
| Urea; Month 18, n=97 | 4.96 ± 1.413 |
| Urea; Month 21, n=75 | 4.94 ± 1.529 |
| Urea; Month 24, n=35 | 4.79 ± 1.313 |
| Urea; Month 27 , n=8 | 5.69 ± 1.668 |
| Urea; Month 30, n=1 | 5.00 ± NA |
| Phosphate; Month 15, n=99 | 1.091 ± 0.1919 |
| Phosphate; Month 18, n=97 | 1.079 ± 0.1844 |
| Phosphate; Month 21, n=75 | 1.083 ± 0.1848 |
| Phosphate; Month 24, n=35 | 1.091 ± 0.1574 |
| Phosphate; Month 27, n=8 | 1.119 ± 0.1252 |
| Phosphate; Month 30, n=1 | 1.300 ± NA |
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
| Micromoles per liter | Participants With HIV Infection |
|---|---|
| Creatinine, Month 15, n=99 | 88.50 ± 13.908 |
| Creatinine, Month 18, n=97 | 94.26 ± 12.797 |
| Creatinine, Month 21, n=75 | 88.09 ± 14.410 |
| Creatinine, Month 24, n=35 | 87.77 ± 14.390 |
| Creatinine, Month 27, n=8 | 88.85 ± 12.854 |
| Creatinine, Month 30, n=1 | 91.90 ± NA |
| Bilirubin, Month 15, n=99 | 9.9 ± 4.67 |
| Bilirubin, Month 18, n=97 | 9.5 ± 4.69 |
| Bilirubin, Month 21 n=75 | 10.7 ± 5.49 |
| Bilirubin, Month 24, n=35 | 10.9 ± 6.69 |
| Bilirubin, Month 27 n=8 | 8.5 ± 4.38 |
| Bilirubin, Month 30, n=1 | 4.0 ± NA |
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
| International units per liter | Participants With HIV Infection |
|---|---|
| ALT, Month 15, n=99 | 27.9 ± 23.06 |
| ALT, Month 18, n=97 | 26.4 ± 16.91 |
| ALT, Month 21, n=75 | 26.2 ± 23.02 |
| ALT, Month 24, n=35 | 24.1 ± 12.23 |
| ALT, Month 27, n=8 | 24.1 ± 8.03 |
| ALT, Month 30 n=1 | 17.0 ± NA |
| ALP, Month 15, n=99 | 66.3 ± 19.77 |
| ALP, Month 18, n=97 | 67.5 ± 22.26 |
| ALP, Month 21, n=75 | 68.3 ± 21.10 |
| ALP, Month 24, n=35 | 65.9 ± 18.86 |
| ALP, Month 27, n=8 | 76.9 ± 15.25 |
| ALP, Month 30, n=1 | 70.0 ± NA |
| AST, Month 15, n=99 | 22.4 ± 10.72 |
| AST, Month 18, n=97 | 25.2 ± 27.55 |
| AST, Month 21, n=75 | 21.7 ± 8.73 |
| AST, Month 24, n=35 | 19.8 ± 5.57 |
| AST, Month 27, n=8 | 20.5 ± 5.32 |
| AST, Month 30, n=1 | 14.0 ± NA |
| Creatine Kinase, Month 15, n=99 | 178.6 ± 198.96 |
| Creatine Kinase, Month 18, n=97 | 338.4 ± 1050.63 |
| Creatine Kinase, Month 21, n=75 | 226.9 ± 374.26 |
| Creatine Kinase, Month 24, n=35 | 151.9 ± 70.67 |
| Creatine Kinase, Month 27, n=8 | 251.9 ± 139.79 |
| Creatine Kinase, Month 30, n=1 | 165.0 ± NA |
Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA.
| Milliliters/seconds/1.73 meter square | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 1.62074 ± 0.285224 |
| Month 18, n=93 | 1.51293 ± 0.275550 |
| Month 21, n=75 | 1.58759 ± 0.293326 |
| Month 24, n=35 | 1.61813 ± 0.292292 |
| Month 27, n=7 | 1.68813 ± 0.187510 |
| Month 30, n=1 | 1.81670 ± NA |
Blood samples were collected for the analysis of clinical chemistry parameter-Lipase.
| Units per liter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 36.0 ± 33.52 |
| Month 18, n=93 | 35.0 ± 30.44 |
| Month 21, n=75 | 34.5 ± 33.39 |
| Month 24, n=35 | 34.6 ± 26.30 |
| Month 27, n=8 | 38.6 ± 30.26 |
| Month 30, n=1 | 35.0 ± NA |
Blood samples were collected for the analysis of clinical chemistry parameter-Albumin.
| Grams per liter | Participants With HIV Infection |
|---|---|
| Month 15, n=99 | 44.5 ± 3.02 |
| Month 18, n=97 | 44.3 ± 2.71 |
| Month 21, n=75 | 44.1 ± 2.49 |
| Month 24, n=35 | 43.7 ± 3.05 |
| Month 27, n=8 | 43.8 ± 2.82 |
| Month 30, n=1 | 39.0 ± NA |
Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted.
No measurements were reported for this outcome.
Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted.
No measurements were reported for this outcome.
Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted.
No measurements were reported for this outcome.
Collected over Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With HIV Infection | 1/115 (0.9%) | 9/115 (7.8%) | 101/115 (87.8%) |
| Event | Participants With HIV Infection |
|---|---|
| Mental status changesPsychiatric disorders | 2/115 |
| Chest painGeneral disorders | 2/115 |
| Abscess limbInfections and infestations | 1/115 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/115 |
| Diabetic ketoacidosisMetabolism and nutrition disorders | 1/115 |
| Drug abusePsychiatric disorders | 1/115 |
| Gun shot woundInjury, poisoning and procedural complications | 1/115 |
| OverdoseInjury, poisoning and procedural complications | 1/115 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 1/115 |
| Staphylococcal infectionInfections and infestations | 1/115 |
| Event | Participants With HIV Infection |
|---|---|
| Injection site painGeneral disorders | 64/115 |
| Injection site discomfortGeneral disorders | 30/115 |
| FatigueGeneral disorders | 23/115 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 20/115 |
| DiarrhoeaGastrointestinal disorders | 20/115 |
| COVID-19Infections and infestations | 18/115 |
| HeadacheNervous system disorders | 16/115 |
| Injection site indurationGeneral disorders | 15/115 |
| CoughRespiratory, thoracic and mediastinal disorders | 15/115 |
| Injection site noduleGeneral disorders | 14/115 |
Baseline characteristics were reported for Safety Population(comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA).Study staff participants only provided input through completion of surveys,semi-structured interviews,facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Demographics for study staff participants were not collected because it was not required per study design
| Age, Continuous(Years) | Participants With HIV Infection |
|---|---|
| Mean | 38.8 ± 11.71 |
| Sex: Female, Male(Participants) | Participants With HIV Infection |
|---|---|
| Female | 16 |
| Male | 99 |
| Race/Ethnicity, Customized(Participants) | Participants With HIV Infection |
|---|---|
| American Indian or Alaskan native | 5 |
| Black or African American | 42 |
| White-White/Caucasian/European heritage | 66 |
| Black or African American and White | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · viivhealthcare.com
Ran from Jul 2019 to primary completion in Oct 2020, 14 months.
Results were first posted in Jan 2022, 1 year 3 months after primary completion.
Of 70 industry-sponsored phase 3 interventional studies under HIV Infections, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 27. This study's 14 months is below that.
Counting every sponsor, half of 124 studies reached it within 25 months; a quarter within 18 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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