A Phase 3 interventional study of Cabotegravir Tablets and Rilpivirine Tablets in HIV Infections, sponsored by ViiV Healthcare. Active, not recruiting at 119 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment
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Among 36 studies testing cabotegravir in HIV Infections — 4 open to participants now, 13 under way, 8 of them phase 3. cabotegravir · HIV Infections.
Among the 36 studies testing cabotegravir in HIV Infections, this one is the 6th largest by enrollment, is one of 4 that started in 2017, is one of 12 in phase 3, reaches primary completion later than 2 of the 12 other live ones, and was the 15th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →4 of the 36 studies testing cabotegravir in HIV Infections are open now, in 3 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in South Africa
Ages up to 10 days · Healthy volunteers
Africa Health Research Institute · Sites in South Africa
Ages 15–30 · Healthy volunteers
Evandro Chagas National Institute of Infectious Disease · Sites in Brazil
Ages 18–30 · Men only · Healthy volunteers
Duke University · Sites in United States
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
cabotegravir: first FDA approval 2021 (VOCABRIA), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 11 · Phase 3 13 · Phase 4 3
First in 2008; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,049 is above the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 200 across the 36 interventional studies. Of the 23 that completed or were terminated, 18 (78%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 36 have an industry lead sponsor. The 7 most frequent:
This study is registered under ViiV Healthcare, one of the names counted as GlaxoSmithKline. Under that name alone:
ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
265 studies in HIV Infections by GlaxoSmithKline: 14 open now, 26 under way, 8 of them phase 3. Of 230 finished, 95 (41%) have results posted.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 3rd largest by enrollment of the 209 interventional ones that give a count, is one of 10 that started in 2017, is one of 65 in phase 3, reaches primary completion later than 3 of the 25 other live ones, and was the 182nd registered.
GlaxoSmithKline’s HIV Infections studies by the year they started, since 1994.
1 of the studies testing cabotegravir in HIV Infections that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06786520ViiV HealthcareA Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults | 2027-03-08 |
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Among the 36 studies testing cabotegravir in HIV Infections, from their registry updates:
Among GlaxoSmithKline’s 265 in HIV Infections:
This tab as a report to print or save as PDF → With an account.
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non- defined as: pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; Documented Bilateral Oophorectomy.
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 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 enrollment.
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, 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.
Exclusion Criteria:
For subjects not transitioning from 201585 (ATLAS):
For Subjects transitioning from 201585 (ATLAS):
For all subjects:
Subjects positive for HBsAg are excluded; Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
(Age x ) / ( x ( square [ ALT ])
Sub-study exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q4W via intramuscular (IM) route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.
Drug: Cabotegravir Tablets · Drug: Rilpivirine Tablets · Drug: Cabotegravir Injectable Suspension · Drug: Rilpivirine Injectable Suspension
Group 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q8W via IM route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.
Drug: Cabotegravir Tablets · Drug: Rilpivirine Tablets · Drug: Cabotegravir Injectable Suspension · Drug: Rilpivirine Injectable Suspension
Group 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to continue CAB LA plus RPV LA Q4W administration via IM route.
Drug: Cabotegravir Injectable Suspension · Drug: Rilpivirine Injectable Suspension
Group 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to receive CAB LA plus RPV LA Q8W via IM route.
Drug: Cabotegravir Injectable Suspension · Drug: Rilpivirine Injectable Suspension
CAB tablets are white to almost white oval shaped film coated 30 mg tablets for oral administration. CAB tablets are to be stored up to 30 degree Celsius and protected from moisture.
RPV tablets are 25 mg tablets that are off-white, round, biconvex, film-coated and debossed on one side with "TMC" and the other side with "25". RPV tablets should be stored at 25 degree Celsius (excursions permitted to 15 degree-30 degree Celsius) and protected from light.
CAB LA injectable suspension is a sterile white to slightly pink suspension containing 200 mg/mL of GSK1265744 as free acid for administration by IM injection. CAB LA injectable suspension is to be stored at up to 30 degree Celsius and should not be frozen.
RPV LA injectable suspension is a sterile white suspension containing 300 mg/mL of RPV as the free base for administration by IM injection. RPV LA injectable suspension should be kept in the outer package and stored at 2-8 degree Celsius and should not be frozen. RPV LA should also be protected from light.
Percentage of Participants With Plasma Human Immunodeficiency Virus-ribonucleic Acid (HIV-RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Week 48
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA + RPV LA Q4W regimen over 48 weeks in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 48
Percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 24
Percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)
Time frame: Week 24
Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) Through Weeks 24 and 48
CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL. Cumulative percentage of participants with protocol defined CVF up to Weeks 24 and 48 has been presented.
Time frame: Weeks 24 and 48
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm at Week 24
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL at Week 24 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI).
Time frame: Weeks 24
Absolute Values for HIV-1 RNA at Week 48
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
Time frame: Weeks 48
Change From Baseline Values for HIV-1 RNA at Week 48
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented.
Time frame: Baseline (Day 1) and Week 48
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) at Week 48
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q8W.
Time frame: Week 48
Change From Baseline Values for CD4+ at Week 48
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q4W. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Week 48
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5% Incidence) and Serious Adverse Events (SAEs)-Maintenance Phase
An adverse event 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. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to actual treatment received.
Time frame: Up to Week 48
Number of Participants With Severity of Adverse Events-Maintenance Phase
Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Time frame: Up to Week 48
Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, glomerular filtration rate (GFR) from creatinine adjusted for bovine serum albumin (BSA), glucose, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) calculation, lipase, phosphate, potassium, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to Week 48
Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. Severity grades were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to Week 48
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
An adverse event 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 withdrawal has been presented.
Time frame: Up to Week 48
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, Glucose, Direct High Density Lipoprotein (HDL) Cholesterol, LDL Cholesterol Calculation and Triglycerides at Week 48
Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, glucose, direct HDL cholesterol, LDL cholesterol calculation and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
Blood samples were collected for the analysis of hematology parameter: erythrocyte MCV. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Hematology Parameter: Erythrocytes Over Time
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Hematology Parameter: Hematocrit Over Time
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Change From Baseline in Hematology Parameter: Hemoglobin Over Time
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48
Number of Participants With Phenotypic Resistance- Maintenance Phase
Phenotypic resistance (PR) was analyzed in participants who met CVF criteria. PR for following Baseline third agent drugs: Integrase inhibitors(INI): bictegravir (BIC), CAB, dolutegravir (DTG), elvitegravir (EVG), raltegravir(RAL); non-nucleoside reverse transcriptase inhibitors(NNRTI): delavirdine(DLV), efavirenz(EFV), etravirine(ETR), nevirapine(NVP), RPV; nucleoside reverse transcriptase inhibitor (NRTI): lamivudine(3TC), abacavir(ABC), emtricitabine(FTC), tenofovir(TDF), zidovudine(ZDV), stavudine(d4T), didanosine(ddI) and protease inhibitors(PI): atazanavir(ATV), darunavir(DRV), fosamprenavir(FPV), indinavir(IDV), lopinavir(LPV), nelfinavir(NFV), ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) is presented. Phenotypic susceptibility was defined based on the fold change (FC) value: resistant (FC\>clinical higher cutoff or biological cutoff), partially sensitive (FC\<=clinical higher cutoff and \> clinical lower cutoff), sensitive(FC\<=clinical lower cutoff or biological cutoff)
Time frame: Up to Week 48 analysis
Number of Participants With Genotypic Resistance-Maintenance Phase
Genotypic resistance was analyzed in participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following Baseline third agent drugs, INI: BIC, DTG, EVG, RAL; NNRTI: DLV, EFV, ETR, NVP, RPV; NRTI: 3TC, ABC, FTC, TDF, ZDV, d4T, ddI and PI: ATV, ATV/ritonavir (r), DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r and TPV/r in participants meeting CVF criteria has been presented.
Time frame: Up to Week 48 analysis
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 Without (w/o) Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants without prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented.
Time frame: Week 48
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48 With >=1 Weeks of Prior Exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W Arm Only
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants with \>=1 weeks of prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented.
Time frame: Week 48
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W Arm Only
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV participants received during the oral lead-in period. Number of participants who selected each of the responses based on their treatment preference is presented.
Time frame: Week 48
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions:LISAT, medication worries (MEDWO) and disclosure worries (DISWO). Total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=\[100 divided by (20 minus 4)\]\*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. Last Observation Carried Forward (LOCF) was used as primary method of analysis. Data for participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in HIV Medication, MEDWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for MEDWO is calculated on a 0-100 scale using the formula: MEDWO 100=\[100 divided by (25 minus 5)\]\*(MEDWO minus 5). A response of 1 in MEDWO score shows medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in DISWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=\[100 divided by (25 minus 5)\]\*(DISWO minus 5). A response of 1 in DISWO score shows disclosure worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Weeks 24 and 48
The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and Weeks 24 and 48
Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and Weeks 24 and 48
Total Treatment Satisfaction Change Score Using HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) at Week 48
The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change. LOCF was used as primary method of analysis. Total treatment satisfaction change score for participants who entered the current study from Q4W arm of ATLAS (NCT number: NCT02951052) and from either standard of care (SOC) arms of ATLAS or the new SOC participants) has been presented.
Time frame: Week 48
Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
The PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 most unfavourable. Dimension scores include bother from ISR, leg movement, sleep and acceptability. Score of a domain is calculated as mean of all items within the domain. Higher scores represent worse perception of injection. LOCF was used as primary method of analysis.
Time frame: Week 8 and Weeks 24 and 48
Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
The PIN questionnaire explores the bother of pain at the injection site and ISRs, anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale ranging from 1(very dissatisfied, extremely, etc.) to 5 (very satisfied, not at all, etc.). Lower scores represent worse perception of injection. LOCF was used as primary method of analysis.
Time frame: Week 8 and Weeks 24 and 48
Change From Baseline in Treatment Acceptance a Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication were analyzed.Items on the scale are rated as 1-5 scores:1:not at all acceptable,2:not very acceptable,3:somewhat acceptable, 4:totally acceptable and 5:I don't know.Total score of the dimension is calculated as the mean of recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:Total Score=(mean of the recoded items in the dimension minus1)divided by2\*100. LOCF was used as primary method of analysis. Data for participants without or with prior exposure has been presented. Baseline value is defined as last available value up to and including the Maintenance treatment. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and Weeks 24 and 48
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK Population comprises of all participants who received CAB and / or RPV and underwent PK sampling during the study and provide at least 1 non-missing CAB and / or RPV plasma concentration value (Non-quantifiable \[NQ\] values will be considered as non-missing values).
Time frame: Pre-dose at Weeks 4, 8, 16, 24, 32, 40 and 48
Plasma Ctrough for RPV LA Evaluable
Blood samples were collected at indicated time points for PK analysis of RPV LA.
Time frame: Pre-dose at Weeks 4, 8, 16, 24, 32, 40 and 48
Area Under the Curve (AUC) for CAB LA
Blood samples were collected at indicated time points to analyze concentration in plasma for CAB LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
Time frame: Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41
AUC for RPV LA
Blood samples were collected at indicated time points to analyze concentration in plasma for RPV LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
Time frame: Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41
Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable
Blood samples were collected at indicated time points to analyze Cmax in plasma for CAB LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
Time frame: Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41
Cmax in Plasma for RPV LA Evaluable
Blood samples were collected at indicated time points to analyze Cmax in plasma for RPV LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
Time frame: Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41
Number of Participants With Different Demographic Parameters for Inter-participant Variability
Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter participant variability for pharmacokinetic parameters.
Time frame: Up to Week 48
Number of Participants With Different Demographic Parameters for Intra-participant Variability
Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of intra participant variability for pharmacokinetic parameters.
Time frame: Up to Week 48
This non-inferiority study evaluated antiviral activity of cabotegravir(CAB) long acting(LA) 600 milligrams(mg) + rilpivirine(RPV) LA 900 mg administered every 8 weeks(Q8W) compared with CAB LA 400 mg+RPV LA 600 mg administered every 4 weeks(Q4W) over a 48-week period in virologically suppressed human immunodeficiency type 1 infection participants.
| Milestone | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Started | 522 | 523 |
| Completed | 0 | 0 |
| Not completed | 522 | 523 |
| Withdrew: On-going | 486 | 481 |
| Withdrew: Withdrawal by subject | 6 | 21 |
| Withdrew: Physician decision | 5 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Pregnancy | 1 | 3 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Lack of efficacy | 9 | 3 |
| Withdrew: Adverse event | 12 | 13 |
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA + RPV LA Q4W regimen over 48 weeks in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
| Percentage of participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Virus-ribonucleic Acid (HIV-RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Week 48 | 1.7 | 1.0 |
Percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)
| Percentage of participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 48 | 94 | 93 |
Percentage of participants with plasma HIV-1 RNA \<50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)
| Percentage of participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 24 | 95 (93 to 97) | 95 (94 to 97) |
CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL. Cumulative percentage of participants with protocol defined CVF up to Weeks 24 and 48 has been presented.
| Percentage of participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Week 24 | 1.3 | 0.2 |
| Week 48 | 1.5 | 0.4 |
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL at Week 24 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI).
| Percentage of participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm at Week 24 | 2.1 (0.9 to 3.3) | 1.5 (0.5 to 2.6) |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
| Log 10 c/mL | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Absolute Values for HIV-1 RNA at Week 48 | 1.599 ± 0.0870 | 1.593 ± 0.0302 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented.
| Log 10 c/mL | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Change From Baseline Values for HIV-1 RNA at Week 48 | 0.007 ± 0.0888 | -0.015 ± 0.1673 |
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q8W.
| Cells per cubic millimeter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Absolute Values for Cluster of Differentiation 4 Plus (CD4+) at Week 48 | 685.9 ± 261.70 | 700.0 ± 278.18 |
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q4W. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
| Cells per cubic millimeter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Change From Baseline Values for CD4+ at Week 48 | 5.3 ± 168.62 | -24.6 ± 199.02 |
An adverse event 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. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to actual treatment received.
| Participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Any non-SAE (>=5%) | 429 | 427 |
| Any SAE | 27 | 19 |
Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
| Participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Grade 1 | 201 | 195 |
| Grade 2 | 231 | 238 |
| Grade 3 | 38 | 43 |
| Grade 4 | 2 | 6 |
| Grade 5 | 1 | 0 |
Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, glomerular filtration rate (GFR) from creatinine adjusted for bovine serum albumin (BSA), glucose, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) calculation, lipase, phosphate, potassium, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
| Participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| ALT, Grade 1 | 45 | 49 |
| ALT, Grade 2 | 10 | 13 |
| ALT, Grade 3 | 1 | 3 |
| ALT, Grade 4 | 1 | 2 |
| Albumin, Grade 1 | 1 | 0 |
| Albumin, Grade 2 | 1 | 1 |
| Albumin, Grade 3 | 0 | 0 |
| Albumin, Grade 4 | 0 | 0 |
| ALP, Grade 1 | 1 | 5 |
| ALP, Grade 2 | 0 | 0 |
| ALP, Grade 3 | 0 | 0 |
| ALP, Grade 4 | 0 | 0 |
| AST, Grade 1 | 32 | 44 |
| AST, Grade 2 | 10 | 13 |
| AST, Grade 3 | 2 | 4 |
| AST, Grade 4 | 1 | 2 |
| Bilirubin, Grade 1 | 27 | 25 |
| Bilirubin, Grade 2 | 7 | 5 |
| Bilirubin, Grade 3 | 1 | 1 |
| Bilirubin, Grade 4 | 1 | 1 |
| CO2, Grade 1 | 98 | 111 |
| CO2, Grade 2 | 2 | 1 |
| CO2, Grade 3 | 0 | 0 |
| CO2, Grade 4 | 0 | 0 |
| Cholesterol, Grade 1 | 50 | 52 |
| Cholesterol, Grade 2 | 31 | 30 |
| Cholesterol, Grade 3 | 2 | 3 |
| Cholesterol, Grade 4 | 0 | 0 |
| Creatinine Kinase, Grade 1 | 41 | 32 |
| Creatinine Kinase, Grade 2 | 22 | 19 |
| Creatinine Kinase, Grade 3 | 7 | 9 |
| Creatinine Kinase, Grade 4 | 9 | 14 |
| Creatinine, Grade 1 | 5 | 9 |
| Creatinine, Grade 2 | 2 | 1 |
| Creatinine, Grade 3 | 0 | 0 |
| Creatinine, Grade 4 | 0 | 0 |
| GFR from creatinine adjusted for BSA, Grade 1 | 0 | 0 |
| GFR from creatinine adjusted for BSA, Grade 2 | 110 | 134 |
| GFR from creatinine adjusted for BSA, Grade 3 | 15 | 19 |
| GFR from creatinine adjusted for BSA, Grade 4 | 0 | 1 |
| Glucose, Grade 1 | 84 | 87 |
| Glucose, Grade 2 | 34 | 43 |
| Glucose, Grade 3 | 3 | 5 |
| Glucose, Grade 4 | 1 | 1 |
| Hyperglycemia, Grade 1 | 80 | 77 |
| Hyperglycemia, Grade 2 | 32 | 38 |
| Hyperglycemia, Grade 3 | 2 | 5 |
| Hyperglycemia, Grade 4 | 0 | 0 |
| Hyperkalemia, Grade 1 | 8 | 2 |
| Hyperkalemia, Grade 2 | 0 | 1 |
| Hyperkalemia, Grade 3 | 0 | 0 |
| Hyperkalemia, Grade 4 | 0 | 1 |
| Hypernatremia, Grade 1 | 6 | 2 |
| Hypernatremia, Grade 2 | 0 | 0 |
| Hypernatremia, Grade 3 | 0 | 0 |
| Hypernatremia, Grade 4 | 0 | 0 |
| Hypoglycemia, Grade 1 | 11 | 13 |
| Hypoglycemia, Grade 2 | 2 | 5 |
| Hypoglycemia, Grade 3 | 1 | 0 |
| Hypoglycemia, Grade 4 | 1 | 1 |
| Hypokalemia, Grade 1 | 10 | 8 |
| Hypokalemia, Grade 2 | 0 | 0 |
| Hypokalemia, Grade 3 | 0 | 0 |
| Hypokalemia, Grade 4 | 0 | 0 |
| Hyponatremia, Grade 1 | 23 | 26 |
| Hyponatremia, Grade 2 | 0 | 1 |
| Hyponatremia, Grade 3 | 0 | 0 |
| Hyponatremia, Grade 4 | 0 | 0 |
| LDL Cholesterol calculation, Grade 1 | 40 | 41 |
| LDL Cholesterol calculation, Grade 2 | 20 | 26 |
| LDL Cholesterol calculation, Grade 3 | 9 | 4 |
| LDL Cholesterol calculation, Grade 4 | 0 | 0 |
| Lipase, Grade 1 | 40 | 44 |
| Lipase, Grade 2 | 31 | 44 |
| Lipase, Grade 3 | 13 | 4 |
| Lipase, Grade 4 | 3 | 6 |
| Phosphate, Grade 1 | 75 | 72 |
| Phosphate, Grade 2 | 20 | 1 |
| Phosphate, Grade 3 | 0 | 2 |
| Phosphate, Grade 4 | 0 | 0 |
| Potassium, Grade 1 | 18 | 10 |
| Potassium, Grade 2 | 0 | 1 |
| Potassium, Grade 3 | 0 | 0 |
| Potassium, Grade 4 | 0 | 1 |
| Sodium, Grade 1 | 29 | 28 |
| Sodium, Grade 2 | 0 | 1 |
| Sodium, Grade 3 | 0 | 0 |
| Sodium, Grade 4 | 0 | 0 |
| Triglycerides, Grade 1 | 51 | 42 |
| Triglycerides, Grade 2 | 11 | 3 |
| Triglycerides, Grade 3 | 4 | 2 |
| Triglycerides, Grade 4 | 0 | 2 |
The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. Severity grades were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
| Participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Hemoglobin, Grade 1 | 9 | 4 |
| Hemoglobin, Grade 2 | 1 | 3 |
| Hemoglobin, Grade 3 | 2 | 4 |
| Hemoglobin, Grade 4 | 0 | 0 |
| Leukocytes, Grade 1 | 12 | 5 |
| Leukocytes, Grade 2 | 0 | 0 |
| Leukocytes, Grade 3 | 1 | 0 |
| Leukocytes, Grade 4 | 0 | 0 |
| Neutrophils, Grade 1 | 7 | 6 |
| Neutrophils, Grade 2 | 8 | 5 |
| Neutrophils, Grade 3 | 1 | 2 |
| Neutrophils, Grade 4 | 2 | 1 |
| Platelets, Grade 1 | 8 | 8 |
| Platelets, Grade 2 | 1 | 1 |
| Platelets, Grade 3 | 1 | 1 |
| Platelets, Grade 4 | 0 | 0 |
An adverse event 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 withdrawal has been presented.
| Percentage of participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase | 2 | 2 |
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| International units per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| ALT, Week 4, n=326, 520 | -1.3 ± 11.11 | 0.1 ± 14.01 |
| ALT, Week 8, n=510, 515 | 0.8 ± 21.28 | 0.3 ± 15.65 |
| ALT, Week 16, n=515, 513 | 1.5 ± 47.60 | -0.7 ± 12.29 |
| ALT, Week 24, n=505, 503 | 1.9 ± 63.03 | -0.3 ± 13.39 |
| ALT, Week 32, n=499, 498 | -0.4 ± 12.60 | 2.4 ± 33.72 |
| ALT, Week 40, n=495, 490 | 0.4 ± 13.50 | 6.6 ± 112.13 |
| ALT, Week 48, n=493, 486 | 1.1 ± 16.39 | 1.6 ± 18.61 |
| ALP, Week 4, n=326, 520 | -5.5 ± 12.09 | -2.1 ± 10.25 |
| ALP, Week 8, n=510, 515 | -4.1 ± 13.07 | -3.3 ± 11.31 |
| ALP, Week 16, n=515, 513 | -4.8 ± 14.65 | -4.2 ± 13.07 |
| ALP, Week 24, n=505, 503 | -5.2 ± 16.04 | -4.0 ± 13.42 |
| ALP, Week 32, n=499, 498 | -5.7 ± 17.14 | -4.1 ± 14.95 |
| ALP, Week 40, n=495, 490 | -5.9 ± 17.61 | -3.9 ± 16.09 |
| ALP, Week 48, n=493, 486 | -6.6 ± 17.18 | -4.5 ± 15.02 |
| AST, Week 4, n=326, 520 | -0.6 ± 13.25 | -0.3 ± 18.47 |
| AST, Week 8, n=510, 515 | 0.6 ± 11.71 | 0.0 ± 14.46 |
| AST, Week 16, n=515, 513 | 1.2 ± 24.79 | -0.3 ± 16.58 |
| AST, Week 24, n=505, 503 | 1.6 ± 53.81 | -0.2 ± 21.65 |
| AST, Week 32, n=499, 498 | -1.6 ± 8.84 | 0.8 ± 34.81 |
| AST, Week 40, n=495, 490 | -1.0 ± 10.14 | 2.5 ± 66.54 |
| AST, Week 48, n=493, 486 | -0.2 ± 12.48 | -0.7 ± 16.12 |
| Creatinine kinase, Week 4, n=326, 520 | 30.2 ± 689.41 | -29.3 ± 717.51 |
| Creatinine kinase, Week 8, n=510, 515 | 24.1 ± 479.84 | -23.7 ± 682.90 |
| Creatinine kinase, Week 16, n=515, 513 | 30.6 ± 692.65 | -4.7 ± 856.65 |
| Creatinine kinase, Week 24, n=505, 503 | -13.6 ± 265.16 | 31.1 ± 1198.22 |
| Creatinine kinase, Week 32, n=499, 498 | -23.3 ± 314.46 | -5.8 ± 787.02 |
| Creatinine kinase, Week 40, n=495, 490 | -12.5 ± 336.08 | 34.2 ± 1288.66 |
| Creatinine kinase, Week 48, n=493, 486 | 17.9 ± 411.70 | -2.9 ± 810.46 |
Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Grams per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Week 4, n=326, 520 | -0.5 ± 2.32 | -0.2 ± 2.45 |
| Week 8, n=510, 515 | -0.3 ± 2.48 | -0.1 ± 2.48 |
| Week 16, n=515, 513 | -0.3 ± 2.56 | -0.4 ± 2.51 |
| Week 24, n=505, 503 | -0.0 ± 2.49 | -0.2 ± 2.59 |
| Week 32, n=499, 498 | -0.2 ± 2.63 | -0.3 ± 2.68 |
| Week 40, n=495, 490 | 0.1 ± 2.68 | -0.3 ± 2.54 |
| Week 48, n=493, 486 | -0.2 ± 2.59 | -0.2 ± 2.60 |
Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Micromoles per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Bilirubin, Week 4, n=326, 520 | 0.4 ± 6.44 | 0.1 ± 5.70 |
| Bilirubin, Week 8, n=510, 515 | 0.4 ± 5.68 | 0.1 ± 5.39 |
| Bilirubin, Week 16, n=515, 513 | 0.5 ± 5.78 | 0.2 ± 5.69 |
| Bilirubin, Week 24, n=505, 503 | 0.8 ± 9.42 | 0.5 ± 5.23 |
| Bilirubin, Week 32, n=499, 498 | 0.5 ± 5.54 | 0.4 ± 5.46 |
| Bilirubin, Week 40, n=495, 490 | 0.7 ± 6.00 | 0.4 ± 5.77 |
| Bilirubin, Week 48, n=493, 486 | 0.4 ± 5.77 | 0.7 ± 4.93 |
| Creatinine, Week 4, n=326, 521 | 0.89 ± 8.768 | -0.36 ± 7.215 |
| Creatinine, Week 8, n=510, 515 | -0.94 ± 8.638 | -0.39 ± 8.191 |
| Creatinine, Week 16, n=515, 513 | -0.24 ± 8.973 | -0.03 ± 8.516 |
| Creatinine, Week 24, n=505, 503 | 0.22 ± 9.085 | 0.94 ± 9.591 |
| Creatinine, Week 32, n=499, 498 | 1.01 ± 9.490 | 2.09 ± 9.313 |
| Creatinine, Week 40, n=495, 490 | 1.02 ± 9.604 | 2.05 ± 9.414 |
| Creatinine, Week 48, n=493, 486 | 1.30 ± 9.813 | 2.30 ± 8.678 |
Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Millimoles per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| CO2, Week 4, n=326, 520 | -0.5 ± 2.29 | -0.7 ± 2.32 |
| CO2, Week 8, n=510, 515 | -0.8 ± 2.12 | -0.8 ± 2.23 |
| CO2, Week 16, n=515, 513 | -1.0 ± 2.31 | -0.9 ± 2.33 |
| CO2, Week 24, n=505, 503 | -0.7 ± 2.38 | -0.7 ± 2.28 |
| CO2, Week 32, n=499, 498 | -0.9 ± 2.31 | -0.8 ± 2.43 |
| CO2, Week 40, n=495, 490 | -0.6 ± 2.33 | -0.7 ± 2.44 |
| CO2, Week 48, n=493, 485 | -0.4 ± 2.32 | -0.4 ± 2.41 |
| Chloride, Week 4, n=326, 520 | 0.6 ± 2.19 | 0.2 ± 2.35 |
| Chloride, Week 8, n=510, 515 | 0.3 ± 2.24 | 0.2 ± 2.34 |
| Chloride, Week 16, n=515, 513 | 0.4 ± 2.30 | 0.2 ± 2.40 |
| Chloride, Week 24, n=505, 503 | 0.1 ± 2.36 | -0.1 ± 2.59 |
| Chloride, Week 32, n=499, 498 | 0.2 ± 2.34 | 0.1 ± 2.64 |
| Chloride, Week 40, n=495, 490 | -0.1 ± 2.46 | 0.0 ± 2.36 |
| Chloride, Week 48, n=493, 486 | -0.0 ± 2.25 | -0.1 ± 2.46 |
| Phosphate, Week 4, n=326, 520 | 0.054 ± 0.182 | 0.018 ± 0.167 |
| Phosphate, Week 8, n=510, 515 | 0.025 ± 0.177 | 0.029 ± 0.160 |
| Phosphate, Week 16, n=515, 513 | 0.017 ± 0.181 | 0.007 ± 0.172 |
| Phosphate, Week 24, n=505, 502 | 0.016 ± 0.170 | -0.004 ± 0.168 |
| Phosphate, Week 32, n=499, 498 | -0.001 ± 0.183 | 0.001 ± 0.172 |
| Phosphate, Week 40, n=495, 490 | 0.014 ± 0.180 | 0.001 ± 0.170 |
| Phosphate, Week 48, n=493, 486 | 0.007 ± 0.169 | 0.010 ± 0.157 |
| Potassium, Week 4, n=326, 520 | 0.03 ± 0.337 | 0.03 ± 0.303 |
| Potassium, Week 8, n=510, 515 | 0.04 ± 0.317 | 0.04 ± 0.331 |
| Potassium, Week 16, n=515, 513 | 0.03 ± 0.328 | 0.03 ± 0.341 |
| Potassium, Week 24, n=505, 503 | 0.04 ± 0.338 | 0.03 ± 0.321 |
| Potassium, Week 32, n=499, 498 | 0.04 ± 0.364 | 0.00 ± 0.340 |
| Potassium, Week 40, n=495, 490 | 0.04 ± 0.351 | 0.02 ± 0.334 |
| Potassium, Week 48, n=493, 486 | 0.04 ± 0.315 | 0.03 ± 0.327 |
| Sodium, Week 4, n=326, 520 | 0.4 ± 2.02 | 0.1 ± 2.11 |
| Sodium, Week 8, n=510, 515 | 0.1 ± 2.14 | 0.2 ± 2.02 |
| Sodium, Week 16, n=515, 513 | 0.0 ± 2.00 | -0.1 ± 2.01 |
| Sodium, Week 24, n=505, 503 | -0.2 ± 2.07 | -0.3 ± 2.20 |
| Sodium, Week 32, n=499, 498 | -0.1 ± 2.10 | -0.1 ± 2.21 |
| Sodium, Week 40, n=495, 490 | -0.3 ± 2.09 | -0.2 ± 2.13 |
| Sodium, Week 48, n=493, 486 | -0.4 ± 2.02 | -0.3 ± 2.21 |
| Urea, Week 4, n=326, 520 | 0.24 ± 1.251 | 0.19 ± 1.227 |
| Urea, Week 8, n=510, 515 | 0.07 ± 1.306 | 0.19 ± 1.336 |
| Urea, Week 16, n=515, 513 | 0.07 ± 1.372 | 0.15 ± 1.320 |
| Urea, Week 24, n=505, 503 | 0.06 ± 1.298 | 0.15 ± 1.270 |
| Urea, Week 32, n=499, 498 | 0.11 ± 1.297 | 0.16 ± 1.356 |
| Urea, Week 40, n=495, 490 | 0.18 ± 1.345 | 0.21 ± 1.412 |
| Urea, Week 48, n=493, 486 | 0.13 ± 1.350 | 0.14 ± 1.457 |
Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, glucose, direct HDL cholesterol, LDL cholesterol calculation and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Millimoles per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Cholesterol, Week 48, n=423, 408 | 0.023 ± 0.742 | 0.075 ± 0.748 |
| Glucose, Week 48, n=478, 470 | 0.16 ± 0.907 | 0.12 ± 1.208 |
| Direct HDL cholesterol, Week 48, n=423, 408 | 0.011 ± 0.292 | -0.000 ± 0.288 |
| LDL cholesterol calculation, Week 48, n=415, 398 | 0.026 ± 0.629 | 0.098 ± 0.585 |
| Triglycerides, Week 48, n=423, 408 | -0.039 ± 0.790 | -0.017 ± 0.880 |
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| milliliters/minute/1.73 square meter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Week 4, n=326, 521 | -0.8 ± 9.05 | 0.4 ± 7.91 |
| Week 8, n=508, 514 | 1.0 ± 9.07 | 0.4 ± 8.62 |
| Week 16, n=515, 513 | -0.2 ± 9.08 | -0.4 ± 9.01 |
| Week 24, n=503, 503 | -0.7 ± 9.67 | -1.7 ± 10.65 |
| Week 32, n=499, 498 | -1.7 ± 10.12 | -3.0 ± 10.19 |
| Week 40, n=494, 489 | -1.7 ± 9.92 | -2.9 ± 9.95 |
| Week 48, n=493, 486 | -1.9 ± 9.96 | -3.3 ± 9.79 |
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Units per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Week 4, n=326, 521 | 1.7 ± 28.76 | 1.1 ± 22.67 |
| Week 8, n=510, 514 | 1.5 ± 23.82 | 1.4 ± 24.74 |
| Week 16, n=515, 513 | 2.7 ± 33.41 | 0.7 ± 18.82 |
| Week 24, n=503, 503 | 0.7 ± 19.71 | 2.6 ± 34.49 |
| Week 32, n=499, 498 | 3.1 ± 35.20 | -0.5 ± 21.91 |
| Week 40, n=494, 486 | 1.3 ± 23.35 | 2.7 ± 30.95 |
| Week 48, n=493, 486 | 3.2 ± 53.46 | 2.9 ± 42.61 |
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| 10^9 cells per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Basophils, Week 4, n=330, 516 | 0.006 ± 0.02751 | 0.003 ± 0.02811 |
| Basophils, Week 8, n=506, 505 | 0.000 ± 0.02682 | 0.002 ± 0.02699 |
| Basophils, Week 16, n=508, 507 | -0.000 ± 0.02651 | 0.001 ± 0.02929 |
| Basophils, Week 24, n=497, 495 | 0.002 ± 0.02809 | 0.002 ± 0.02803 |
| Basophils, Week 32, n=489, 486 | 0.005 ± 0.02708 | 0.003 ± 0.02988 |
| Basophils, Week 40, n=479, 472 | 0.004 ± 0.02716 | 0.004 ± 0.02772 |
| Basophils, Week 48, n=486, 478 | 0.005 ± 0.02730 | 0.003 ± 0.02926 |
| Eosinophils, Week 4, n=330, 516 | 0.031 ± 0.13775 | 0.015 ± 0.15112 |
| Eosinophils, Week 8, n=506, 505 | 0.015 ± 0.14391 | 0.012 ± 0.13314 |
| Eosinophils, Week 16, n=508, 507 | 0.001 ± 0.13474 | 0.010 ± 0.13012 |
| Eosinophils, Week 24, n=497, 495 | 0.001 ± 0.13607 | 0.009 ± 0.12836 |
| Eosinophils, Week 32, n=489, 486 | 0.005 ± 0.12762 | 0.011 ± 0.13810 |
| Eosinophils, Week 40, n=479, 472 | 0.006 ± 0.13578 | 0.009 ± 0.12297 |
| Eosinophils, Week 48, n=486, 478 | 0.001 ± 0.12444 | 0.002 ± 0.12646 |
| Leukocytes, Week 4, n=331, 520 | 0.437 ± 1.5653 | 0.335 ± 1.6343 |
| Leukocytes, Week 8, n=508, 507 | 0.110 ± 1.5863 | 0.214 ± 1.6109 |
| Leukocytes, Week 16, n=509, 507 | 0.050 ± 1.4281 | 0.139 ± 1.6384 |
| Leukocytes, Week 24, n=499, 497 | 0.148 ± 1.5229 | 0.139 ± 1.6301 |
| Leukocytes, Week 32, n=491, 489 | 0.185 ± 1.5455 | 0.111 ± 1.6454 |
| Leukocytes, Week 40, n=480, 476 | 0.177 ± 1.6601 | 0.100 ± 1.8042 |
| Leukocytes, Week 48, n=488, 478 | -0.007 ± 1.5561 | -0.012 ± 1.6035 |
| Lymphocytes, Week 4, n=330, 516 | 0.187 ± 0.44013 | 0.063 ± 0.42683 |
| Lymphocytes, Week 8, n=506, 505 | 0.040 ± 0.39452 | 0.039 ± 0.44987 |
| Lymphocytes, Week 16, n=508, 507 | 0.060 ± 0.43470 | 0.033 ± 0.44030 |
| Lymphocytes, Week 24, n=497, 495 | 0.081 ± 0.41863 | 0.061 ± 0.46240 |
| Lymphocytes, Week 32, n=489, 486 | 0.119 ± 0.46387 | 0.096 ± 0.45178 |
| Lymphocytes, Week 40, n=479, 472 | 0.126 ± 0.44614 | 0.107 ± 0.50590 |
| Lymphocytes, Week 48, n=486, 478 | 0.063 ± 0.43255 | 0.049 ± 0.48991 |
| Monocytes, Week 4, n=330, 516 | 0.051 ± 0.14208 | 0.021 ± 0.13359 |
| Monocytes, Week 8, n=506, 505 | 0.003 ± 0.12080 | 0.003 ± 0.14270 |
| Monocytes, Week 16, n=508, 507 | -0.002 ± 0.12804 | -0.007 ± 0.14361 |
| Monocytes, Week 24, n=497, 495 | 0.019 ± 0.13460 | 0.020 ± 0.14458 |
| Monocytes, Week 32, n=489, 486 | 0.048 ± 0.13969 | 0.039 ± 0.14531 |
| Monocytes, Week 40, n=479, 472 | 0.060 ± 0.13570 | 0.060 ± 0.15692 |
| Monocytes, Week 48, n=486, 478 | 0.030 ± 0.13329 | 0.033 ± 0.13116 |
| Neutrophils, Week 4, n=330, 516 | 0.152 ± 1.44916 | 0.228 ± 1.48979 |
| Neutrophils, Week 8, n=506, 505 | 0.035 ± 1.49397 | 0.141 ± 1.48054 |
| Neutrophils, Week 16, n=508, 507 | -0.018 ± 1.34384 | 0.082 ± 1.52187 |
| Neutrophils, Week 24, n=497, 495 | 0.047 ± 1.36697 | 0.027 ± 1.46192 |
| Neutrophils, Week 32, n=489, 486 | 0.001 ± 1.43051 | -0.054 ± 1.53192 |
| Neutrophils, Week 40, n=479, 472 | -0.021 ± 1.53092 | -0.090 ± 1.58850 |
| Neutrophils, Week 48, n=486, 478 | -0.108 ± 1.39875 | -0.118 ± 1.37189 |
| Platelets, Week 4, n=329, 518 | 2.09 ± 32.330 | 5.91 ± 39.613 |
| Platelets, Week 8, n=506, 507 | -0.62 ± 35.873 | 0.27 ± 34.345 |
| Platelets, Week 16, n=498, 505 | 0.01 ± 35.207 | -1.70 ± 34.072 |
| Platelets, Week 24, n=496, 496 | 0.26 ± 36.085 | -2.53 ± 35.214 |
| Platelets, Week 32, n=487, 486 | 1.67 ± 40.601 | -1.76 ± 37.490 |
| Platelets, Week 40, n=478, 472 | 0.38 ± 38.636 | 0.32 ± 38.028 |
| Platelets, Week 48, n=489, 474 | 0.06 ± 39.549 | -1.51 ± 35.440 |
Blood samples were collected for the analysis of hematology parameter: erythrocyte MCV. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Femtoliters | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Week 4, n=331, 520 | -0.32 ± 2.136 | -0.13 ± 2.322 |
| Week 8, n=509, 510 | -1.16 ± 3.270 | -0.84 ± 3.132 |
| Week 16, n=509, 507 | -1.99 ± 4.583 | -1.84 ± 4.370 |
| Week 24, n=500, 498 | -2.46 ± 5.085 | -2.41 ± 4.777 |
| Week 32, n=491, 491 | -3.17 ± 5.005 | -2.75 ± 4.682 |
| Week 40, n=481, 476 | -3.35 ± 4.740 | -3.15 ± 4.578 |
| Week 48, n=489, 478 | -3.28 ± 5.000 | -3.08 ± 4.797 |
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| 10^12 cells per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Week 4, n=331, 520 | 0.033 ± 0.2206 | 0.024 ± 0.2211 |
| Week 8, n=509, 510 | 0.092 ± 0.2669 | 0.083 ± 0.2651 |
| Week 16, n=509, 507 | 0.182 ± 0.3050 | 0.162 ± 0.3222 |
| Week 24, n=500, 498 | 0.209 ± 0.3071 | 0.170 ± 0.3225 |
| Week 32, n=491, 491 | 0.189 ± 0.3145 | 0.150 ± 0.3337 |
| Week 40, n=481, 476 | 0.229 ± 0.3217 | 0.157 ± 0.3184 |
| Week 48, n=489, 478 | 0.188 ± 0.3288 | 0.170 ± 0.3329 |
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Proportion of red blood cells in blood | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Week 4, n=331, 520 | 0.002 ± 0.02088 | 0.002 ± 0.02202 |
| Week 8, n=509, 510 | 0.004 ± 0.02274 | 0.004 ± 0.02362 |
| Week 16, n=509, 507 | 0.008 ± 0.02290 | 0.007 ± 0.02485 |
| Week 24, n=500, 498 | 0.008 ± 0.02219 | 0.004 ± 0.02413 |
| Week 32, n=491, 491 | 0.003 ± 0.02352 | 0.001 ± 0.02469 |
| Week 40, n=481, 476 | 0.006 ± 0.02323 | 0.000 ± 0.02378 |
| Week 48, n=489, 478 | 0.003 ± 0.02414 | 0.001 ± 0.02565 |
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Grams per liter | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Week 4, n=331, 520 | 0.08 ± 6.425 | -0.16 ± 6.797 |
| Week 8, n=509, 510 | 0.28 ± 7.028 | -0.05 ± 7.419 |
| Week 16, n=509, 507 | 0.44 ± 6.979 | 0.05 ± 7.531 |
| Week 24, n=501, 498 | 1.48 ± 7.013 | 0.45 ± 7.488 |
| Week 32, n=491, 491 | 1.11 ± 7.633 | 0.05 ± 8.041 |
| Week 40, n=481, 476 | 1.36 ± 7.503 | -0.47 ± 7.788 |
| Week 48, n=489, 478 | -0.13 ± 7.631 | -0.80 ± 8.462 |
Phenotypic resistance (PR) was analyzed in participants who met CVF criteria. PR for following Baseline third agent drugs: Integrase inhibitors(INI): bictegravir (BIC), CAB, dolutegravir (DTG), elvitegravir (EVG), raltegravir(RAL); non-nucleoside reverse transcriptase inhibitors(NNRTI): delavirdine(DLV), efavirenz(EFV), etravirine(ETR), nevirapine(NVP), RPV; nucleoside reverse transcriptase inhibitor (NRTI): lamivudine(3TC), abacavir(ABC), emtricitabine(FTC), tenofovir(TDF), zidovudine(ZDV), stavudine(d4T), didanosine(ddI) and protease inhibitors(PI): atazanavir(ATV), darunavir(DRV), fosamprenavir(FPV), indinavir(IDV), lopinavir(LPV), nelfinavir(NFV), ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) is presented. Phenotypic susceptibility was defined based on the fold change (FC) value: resistant (FC\>clinical higher cutoff or biological cutoff), partially sensitive (FC\<=clinical higher cutoff and \> clinical lower cutoff), sensitive(FC\<=clinical lower cutoff or biological cutoff)
| Participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| INI, BIC, resistant, n=6, 2 | 0 | 0 |
| INI, BIC, sensitive, n=6, 2 | 6 | 2 |
| INI, CAB, resistant, n=6, 2 | 3 | 1 |
| INI, CAB, sensitive, n=6, 2 | 3 | 1 |
| INI, DTG, resistant, n=6, 2 | 0 | 0 |
| INI, DTG, partially sensitive, n=6, 2 | 0 | 0 |
| INI, DTG, sensitive, n=6, 2 | 6 | 2 |
| INI, EVG, resistant, n=6, 2 | 4 | 2 |
| INI, EVG, sensitive, n=6, 2 | 2 | 0 |
| INI, RAL, resistant, n=6, 2 | 4 | 2 |
| INI, RAL, sensitive, n=6, 2 | 2 | 0 |
| NNRTI, DLV, resistant, n=7, 2 | 6 | 2 |
| NNRTI, DLV, sensitive, n=7, 2 | 1 | 0 |
| NNRTI, EFV, resistant, n=7, 2 | 5 | 2 |
| NNRTI, EFV, sensitive, n=7, 2 | 2 | 0 |
| NNRTI, ETR, resistant, n=7, 2 | 0 | 2 |
| NNRTI, ETR, partially sensitive, n=7, 2 | 4 | 0 |
| NNRTI, ETR, sensitive, n=7, 2 | 3 | 0 |
| NNRTI, NVP, resistant, n=7, 2 | 6 | 2 |
| NNRTI, NVP, sensitive, n=7, 2 | 1 | 0 |
| NNRTI, RPV, resistant, n=7, 2 | 6 | 2 |
| NNRTI, RPV, sensitive, n=7, 2 | 1 | 0 |
| NRTI, 3TC, resistant, n=7, 2 | 1 | 1 |
| NRTI, 3TC, sensitive, n=7, 2 | 6 | 1 |
| NRTI, ABC, resistant, n=7, 2 | 0 | 0 |
| NRTI, ABC, partially sensitive, n=7, 2 | 0 | 0 |
| NRTI, ABC, sensitive, n=7, 2 | 7 | 2 |
| NRTI, FTC, resistant, n=7, 2 | 1 | 1 |
| NRTI, FTC, sensitive, n=7, 2 | 6 | 1 |
| NRTI, TDF, resistant, n=7, 2 | 0 | 0 |
| NRTI, TDF, partially sensitive, n=7, 2 | 0 | 1 |
| NRTI, TDF, sensitive, n=7, 2 | 7 | 1 |
| NRTI, ZDV, resistant, n=7, 2 | 0 | 2 |
| NRTI, ZDV, sensitive, n=7, 2 | 7 | 0 |
| NRTI, d4T, resistant, n=7, 2 | 0 | 0 |
| NRTI, d4T, sensitive, n=7, 2 | 7 | 2 |
| NRTI, ddI, resistant, n=7, 2 | 0 | 0 |
| NRTI, ddI, partially sensitive, n=7, 2 | 0 | 0 |
| NRTI, ddI, sensitive, n=7, 2 | 7 | 2 |
| PI, ATV, resistant, n=7, 2 | 0 | 0 |
| PI, ATV, sensitive, n=7, 2 | 7 | 2 |
| PI, DRV, resistant, n=7, 2 | 0 | 0 |
| PI, DRV, partially sensitive, n=7, 2 | 0 | 0 |
| PI, DRV, sensitive, n=7, 2 | 7 | 2 |
| PI, FPV, resistant, n=7, 2 | 0 | 0 |
| PI, FPV, partially sensitive, n=7, 2 | 0 | 0 |
| PI, FPV, sensitive, n=7, 2 | 7 | 2 |
| PI, IDV, resistant, n=7, 2 | 0 | 0 |
| PI, IDV, sensitive, n=7, 2 | 7 | 2 |
| PI, LPV, resistant, n=7, 2 | 0 | 0 |
| PI, LPV, partially sensitive, n=7, 2 | 0 | 0 |
| PI, LPV, sensitive, n=7, 2 | 7 | 2 |
| PI, NFV, resistant, n=7, 2 | 0 | 1 |
| PI, NFV, sensitive, n=7, 2 | 7 | 1 |
| PI, RTV, resistant, n=7, 2 | 0 | 1 |
| PI, RTV, sensitive, n=7, 2 | 7 | 1 |
| PI, SQV, resistant, n=7, 2 | 0 | 0 |
| PI, SQV, partially sensitive, n=7, 2 | 0 | 0 |
| PI, SQV, sensitive, n=7, 2 | 7 | 2 |
| PI, TPV, resistant, n=7, 2 | 0 | 0 |
| PI, TPV, partially sensitive, n=7, 2 | 0 | 0 |
| PI, TPV, sensitive, n=7, 2 | 7 | 2 |
Genotypic resistance was analyzed in participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following Baseline third agent drugs, INI: BIC, DTG, EVG, RAL; NNRTI: DLV, EFV, ETR, NVP, RPV; NRTI: 3TC, ABC, FTC, TDF, ZDV, d4T, ddI and PI: ATV, ATV/ritonavir (r), DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r and TPV/r in participants meeting CVF criteria has been presented.
| Participants | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| INI, BIC, resistant, n=6, 2 | 1 | 0 |
| INI, BIC, resistance possible, n=6, 2 | 2 | 1 |
| INI, BIC, sensitive, n=6, 2 | 3 | 1 |
| INI, DTG, resistant, n=6, 2 | 1 | 0 |
| INI, DTG, resistance possible, n=6, 2 | 2 | 1 |
| INI, DTG, sensitive, n=6, 2 | 3 | 1 |
| INI, EVG, resistant, n=6, 2 | 4 | 2 |
| INI, EVG, resistance possible, n=6, 2 | 0 | 0 |
| INI, EVG, sensitive, n=6, 2 | 2 | 0 |
| INI, RAL, resistant, n=6, 2 | 4 | 2 |
| INI, RAL, resistance possible, n=6, 2 | 0 | 0 |
| INI, RAL, sensitive, n=6, 2 | 2 | 0 |
| NNRTI, DLV, resistant, n=8, 2 | 2 | 1 |
| NNRTI, DLV, resistance possible, n=8, 2 | 2 | 1 |
| NNRTI, DLV, sensitive, n=8, 2 | 4 | 0 |
| NNRTI, EFV, resistant, n=8, 2 | 4 | 2 |
| NNRTI, EFV, resistance possible, n=8, 2 | 2 | 0 |
| NNRTI, EFV, sensitive, n=8, 2 | 2 | 0 |
| NNRTI, ETR, resistant, n=8, 2 | 0 | 1 |
| NNRTI, ETR, resistance possible, n=8, 2 | 2 | 1 |
| NNRTI, ETR, sensitive, n=8, 2 | 6 | 0 |
| NNRTI, NVP, resistant, n=8, 2 | 4 | 2 |
| NNRTI, NVP, resistance possible, n=8, 2 | 2 | 0 |
| NNRTI, NVP, sensitive, n=8, 2 | 2 | 0 |
| NNRTI, RPV, resistant, n=8, 2 | 6 | 1 |
| NNRTI, RPV, resistance possible, n=8, 2 | 0 | 0 |
| NNRTI, RPV, sensitive, n=8, 2 | 2 | 1 |
| NRTI, 3TC, resistant, n=8, 2 | 1 | 1 |
| NRTI, 3TC, resistance possible, n=8, 2 | 0 | 0 |
| NRTI, 3TC, sensitive, n=8, 2 | 7 | 1 |
| NRTI, ABC, resistant, n=8, 2 | 0 | 0 |
| NRTI, ABC, resistance possible, n=8, 2 | 0 | 1 |
| NRTI, ABC, sensitive, n=8, 2 | 8 | 1 |
| NRTI, FTC, resistant, n=8, 2 | 1 | 1 |
| NRTI, FTC, resistance possible, n=8, 2 | 0 | 0 |
| NRTI, FTC, sensitive, n=8, 2 | 7 | 1 |
| NRTI, TDF, resistant, n=8, 2 | 0 | 1 |
| NRTI, TDF, resistance possible, n=8, 2 | 0 | 0 |
| NRTI, TDF, sensitive, n=8, 2 | 8 | 1 |
| NRTI, ZDV, resistant, n=8, 2 | 0 | 1 |
| NRTI, ZDV, resistance possible, n=8, 2 | 0 | 0 |
| NRTI, ZDV, sensitive, n=8, 2 | 8 | 1 |
| NRTI, d4T, resistant, n=8, 2 | 0 | 1 |
| NRTI, d4T, resistance possible, n=8, 2 | 0 | 0 |
| NRTI, d4T, sensitive, n=8, 2 | 8 | 1 |
| NRTI, ddI, resistant, n=8, 2 | 0 | 1 |
| NRTI, ddI, resistance possible, n=8, 2 | 1 | 0 |
| NRTI, ddI, sensitive, n=8, 2 | 7 | 1 |
| PI, ATV, resistant, n=8, 2 | 0 | 1 |
| PI, ATV, resistance possible, n=8, 2 | 0 | 0 |
| PI, ATV, sensitive, n=8, 2 | 8 | 1 |
| PI, ATV/r, resistant, n=8, 2 | 0 | 0 |
| PI, ATV/r, resistance possible, n=8, 2 | 0 | 1 |
| PI, ATV/r, sensitive, n=8, 2 | 8 | 1 |
| PI, DRV/r, resistant, n=8, 2 | 0 | 0 |
| PI, DRV/r, resistance possible, n=8, 2 | 0 | 0 |
| PI, DRV/r, sensitive, n=8, 2 | 8 | 2 |
| PI, FPV/r, resistant, n=8, 2 | 0 | 0 |
| PI, FPV/r, resistance possible, n=8, 2 | 0 | 0 |
| PI, FPV/r, sensitive, n=8, 2 | 8 | 2 |
| PI, IDV/r, resistant, n=8, 2 | 0 | 0 |
| PI, IDV/r, resistance possible, n=8, 2 | 0 | 1 |
| PI, IDV/r, sensitive, n=8, 2 | 8 | 1 |
| PI, LPV/r, resistant, n=8, 2 | 0 | 0 |
| PI, LPV/r, resistance possible, n=8, 2 | 0 | 0 |
| PI, LPV/r, sensitive, n=8, 2 | 8 | 2 |
| PI, NFV, resistant, n=8, 2 | 0 | 1 |
| PI, NFV, resistance possible, n=8, 2 | 0 | 0 |
| PI, NFV, sensitive, n=8, 2 | 8 | 1 |
| PI, RTV, resistant, n=8, 2 | 0 | 1 |
| PI, RTV, resistance possible, n=8, 2 | 0 | 0 |
| PI, RTV, sensitive, n=8, 2 | 8 | 1 |
| PI, SQV/r, resistant, n=8, 2 | 0 | 0 |
| PI, SQV/r, resistance possible, n=8, 2 | 0 | 0 |
| PI, SQV/r, sensitive, n=8, 2 | 8 | 2 |
| PI, TPV/r, resistant, n=8, 2 | 0 | 1 |
| PI, TPV/r, resistance possible, n=8, 2 | 0 | 0 |
| PI, TPV/r, sensitive, n=8, 2 | 8 | 1 |
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants without prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented.
| Participants | CAB LA + RPV LA Q8W |
|---|---|
| Injectable LA HIV treatment Q4W | 0 |
| Injectable LA HIV treatment Q8W | 300 |
| Oral daily HIV treatment | 4 |
| No preference | 2 |
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants with \>=1 weeks of prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented.
| Participants | CAB LA + RPV LA Q8W |
|---|---|
| Injectable LA HIV treatment Q4W | 6 |
| Injectable LA HIV treatment Q8W | 179 |
| Oral daily HIV treatment | 4 |
| No preference | 2 |
Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV participants received during the oral lead-in period. Number of participants who selected each of the responses based on their treatment preference is presented.
| Participants | CAB LA + RPV LA Q4W |
|---|---|
| Injectable LA HIV treatment Q4W | 468 |
| Injectable LA HIV treatment Q8W | 0 |
| Oral daily HIV treatment | 16 |
| No preference | 13 |
The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions:LISAT, medication worries (MEDWO) and disclosure worries (DISWO). Total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=\[100 divided by (20 minus 4)\]\*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. Last Observation Carried Forward (LOCF) was used as primary method of analysis. Data for participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Without exposure, Week 24, n=318, 324 | 1.5 ± 14.87 | -0.5 ± 18.00 |
| Without exposure, Week 48, n=319, 324 | -0.8 ± 15.24 | 0.6 ± 17.51 |
| With exposure, Week 24, n=192, 194 | -0.8 ± 14.31 | 0.8 ± 13.73 |
| With exposure, Week 48, n=192, 194 | 0.3 ± 14.03 | -1.3 ± 14.50 |
The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for MEDWO is calculated on a 0-100 scale using the formula: MEDWO 100=\[100 divided by (25 minus 5)\]\*(MEDWO minus 5). A response of 1 in MEDWO score shows medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Without exposure, Week 24, n=318, 324 | 2.7 ± 16.53 | 2.6 ± 15.61 |
| Without exposure, Week 48, n=319, 324 | 3.0 ± 15.87 | 1.9 ± 15.97 |
| With exposure, Week 24, n=192, 194 | 0.7 ± 10.57 | 1.7 ± 14.86 |
| With exposure, Week 48, n=192, 194 | 1.3 ± 8.82 | 1.3 ± 17.95 |
The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=\[100 divided by (25 minus 5)\]\*(DISWO minus 5). A response of 1 in DISWO score shows disclosure worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Without exposure, Week 24, n=317, 324 | 1.4 ± 25.58 | 1.2 ± 23.18 |
| Without exposure, Week 48, n=318, 324 | -0.5 ± 28.14 | -0.5 ± 23.86 |
| With exposure, Week 24, n=192, 194 | 0.9 ± 21.13 | 1.8 ± 24.20 |
| With exposure, Week 48, n=192, 194 | -0.6 ± 24.11 | 1.5 ± 26.84 |
The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Without exposure, Week 24, n=319, 323 | 4.63 ± 9.818 | 4.44 ± 9.709 |
| Without exposure, Week 48, n=319, 323 | 4.42 ± 10.351 | 3.55 ± 10.224 |
| With exposure, Week 24, n=191, 193 | 0.55 ± 5.050 | 0.55 ± 5.347 |
| With exposure, Week 48, n=191, 194 | 0.40 ± 5.242 | -0.01 ± 6.521 |
HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks \[without exposure\] and \>=1 Weeks \[with exposure\]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Item 1, Without exposure, Week 24, n=319, 323 | 0.3 ± 1.19 | 0.3 ± 1.18 |
| Item 1, Without exposure, Week 48, n=319, 323 | 0.3 ± 1.23 | 0.2 ± 1.27 |
| Item 1, With exposure, Week 24, n=191, 193 | 0.1 ± 0.77 | 0.0 ± 0.78 |
| Item 1, With exposure, Week 48, n=191, 194 | 0.1 ± 0.81 | 0.0 ± 0.90 |
| Item 2, Without exposure, Week 24, n=319, 323 | 0.0 ± 0.73 | 0.1 ± 0.67 |
| Item 2, Without exposure, Week 48, n=319, 323 | 0.0 ± 0.78 | 0.0 ± 0.65 |
| Item 2, With exposure, Week 24, n=191, 193 | 0.0 ± 0.42 | 0.1 ± 0.61 |
| Item 2, With exposure, Week 48, n=191, 194 | 0.0 ± 0.49 | 0.1 ± 0.63 |
| Item 3, Without exposure, Week 24, n=319, 323 | 0.0 ± 1.42 | 0.0 ± 1.49 |
| Item 3, Without exposure, Week 48, n=319, 323 | 0.0 ± 1.45 | 0.0 ± 1.48 |
| Item 3, With exposure, Week 24, n=191, 193 | 0.0 ± 0.82 | 0.1 ± 1.03 |
| Item 3, With exposure, Week 48, n=191, 194 | 0.0 ± 1.05 | 0.0 ± 1.20 |
| Item 4, Without exposure, Week 24, n=319, 323 | 0.3 ± 1.05 | 0.3 ± 1.28 |
| Item 4, Without exposure, Week 48, n=319, 323 | 0.2 ± 1.20 | 0.2 ± 1.28 |
| Item 4, With exposure, Week 24, n=191, 193 | 0.1 ± 0.73 | 0.0 ± 0.80 |
| Item 4, With exposure, Week 48, n=191, 194 | 0.1 ± 0.73 | 0.0 ± 0.98 |
| Item 5, Without exposure, Week 24, n=319, 323 | 0.7 ± 1.41 | 0.6 ± 1.37 |
| Item 5, Without exposure, Week 48, n=319, 323 | 0.7 ± 1.36 | 0.5 ± 1.42 |
| Item 5, With exposure, Week 24, n=191, 193 | 0.0 ± 0.58 | 0.1 ± 0.72 |
| Item 5, With exposure, Week 48, n=191, 194 | 0.0 ± 0.69 | 0.0 ± 0.88 |
| Item 6, Without exposure, Week 24, n=319, 323 | 0.9 ± 1.72 | 0.8 ± 1.71 |
| Item 6, Without exposure, Week 48, n=319, 323 | 0.8 ± 1.71 | 0.8 ± 1.80 |
| Item 6, With exposure, Week 24, n=191, 193 | 0.2 ± 0.96 | 0.1 ± 0.90 |
| Item 6, With exposure, Week 48, n=191, 194 | 0.1 ± 1.13 | -0.1 ± 1.12 |
| Item 7, Without exposure, Week 24, n=319, 323 | 0.3 ± 0.78 | 0.2 ± 0.98 |
| Item 7, Without exposure, Week 48, n=319, 323 | 0.2 ± 0.94 | 0.2 ± 0.92 |
| Item 7, With exposure, Week 24, n=191, 193 | 0.0 ± 0.55 | 0.0 ± 0.70 |
| Item 7, With exposure, Week 48, n=191, 194 | 0.1 ± 0.73 | 0.1 ± 0.69 |
| Item 8, Without exposure, Week 24, n=318, 322 | 0.5 ± 1.31 | 0.6 ± 1.30 |
| Item 8, Without exposure, Week 48, n=319, 323 | 0.5 ± 1.31 | 0.5 ± 1.41 |
| Item 8, With exposure, Week 24, n=191, 194 | 0.1 ± 0.61 | 0.1 ± 0.58 |
| Item 8, With exposure, Week 48, n=191, 194 | 0.0 ± 0.64 | 0.0 ± 0.80 |
| Item 9, Without exposure, Week 24, n=319, 322 | 0.4 ± 1.16 | 0.4 ± 1.30 |
| Item 9, Without exposure, Week 48, n=319, 323 | 0.4 ± 1.23 | 0.3 ± 1.36 |
| Item 9, With exposure, Week 24, n=191, 194 | 0.0 ± 0.52 | 0.0 ± 0.72 |
| Item 9, With exposure, Week 48, n=191, 194 | 0.1 ± 0.55 | 0.0 ± 0.85 |
| Item 10, Without exposure, Week 24, n=319, 322 | 0.8 ± 1.44 | 0.9 ± 1.50 |
| Item 10, Without exposure, Week 48, n=319, 323 | 0.8 ± 1.52 | 0.7 ± 1.63 |
| Item 10, With exposure, Week 24, n=191, 194 | 0.0 ± 0.78 | 0.0 ± 0.67 |
| Item 10, With exposure, Week 48, n=191, 194 | 0.0 ± 0.79 | 0.0 ± 0.77 |
| Item 11, Without exposure, Week 24, n=319, 322 | 0.4 ± 1.22 | 0.4 ± 1.25 |
| Item 11, Without exposure, Week 48, n=319, 323 | 0.4 ± 1.26 | 0.3 ± 1.31 |
| Item 11, With exposure, Week 24, n=191, 194 | 0.0 ± 0.73 | 0.1 ± 0.65 |
| Item 11, With exposure, Week 48, n=191, 194 | 0.0 ± 0.62 | -0.1 ± 0.84 |
| Item 12, Without exposure, Week 24, n=319, 322 | -0.4 ± 1.46 | -0.4 ± 1.48 |
| Item 12, Without exposure, Week 48, n=319, 323 | -0.3 ± 1.46 | -0.5 ± 1.57 |
| Item 12, With exposure, Week 24, n=191, 194 | -0.1 ± 0.92 | 0.0 ± 0.92 |
| Item 12, With exposure, Week 48, n=191, 194 | -0.1 ± 1.08 | 0.0 ± 1.02 |
The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change. LOCF was used as primary method of analysis. Total treatment satisfaction change score for participants who entered the current study from Q4W arm of ATLAS (NCT number: NCT02951052) and from either standard of care (SOC) arms of ATLAS or the new SOC participants) has been presented.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Q4W ATLAS, n=124, 125 | 29.1 ± 6.72 | 24.7 ± 12.33 |
| SOC, n=380, 382 | 28.9 ± 7.68 | 27.3 ± 9.50 |
The PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 most unfavourable. Dimension scores include bother from ISR, leg movement, sleep and acceptability. Score of a domain is calculated as mean of all items within the domain. Higher scores represent worse perception of injection. LOCF was used as primary method of analysis.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Bother of ISRs, Week 24, n=515, 515 | -0.00 ± 0.459 | -0.01 ± 0.509 |
| Bother of ISRs, Week 48, n=515, 515 | -0.00 ± 0.531 | 0.01 ± 0.543 |
| Leg Movement, Week 24, n=515, 514 | -0.11 ± 0.804 | -0.23 ± 0.809 |
| Leg Movement, Week 48, n=515, 514 | -0.12 ± 0.818 | -0.24 ± 0.789 |
| Sleep, Week 24, n=515, 514 | -0.00 ± 0.772 | -0.20 ± 0.793 |
| Sleep, Week 48, n=515, 514 | -0.03 ± 0.814 | -0.18 ± 0.804 |
| Acceptance, Week 24, n=514, 515 | -0.13 ± 0.813 | -0.13 ± 0.837 |
| Acceptance, Week 48, n=514, 515 | -0.18 ± 0.829 | -0.13 ± 0.880 |
The PIN questionnaire explores the bother of pain at the injection site and ISRs, anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale ranging from 1(very dissatisfied, extremely, etc.) to 5 (very satisfied, not at all, etc.). Lower scores represent worse perception of injection. LOCF was used as primary method of analysis.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Anxiety before, Week 24, n=515, 515 | 0.0 ± 0.83 | -0.1 ± 0.85 |
| Anxiety before, Week 48, n=515, 515 | -0.1 ± 0.82 | -0.1 ± 0.85 |
| Pain, Week 24, n=515, 515 | 0.1 ± 0.83 | 0.1 ± 0.84 |
| Pain, Week 48, n=515, 515 | 0.0 ± 0.85 | 0.0 ± 0.84 |
| Satisfaction, Week 24, n=514, 515 | 0.1 ± 0.77 | -0.0 ± 0.77 |
| Satisfaction, Week 48, n=514, 515 | -0.0 ± 0.77 | -0.0 ± 0.84 |
| Anxiety after, Week 24, n=514, 515 | -0.0 ± 0.76 | 0.0 ± 0.83 |
| Anxiety after, Week 48, n=514, 515 | -0.1 ± 0.79 | -0.1 ± 0.89 |
| Willingness, Week 24, n=514, 514 | -0.1 ± 0.55 | -0.1 ± 0.65 |
| Willingness, Week 48, n=514, 514 | -0.0 ± 0.66 | -0.1 ± 0.72 |
The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication were analyzed.Items on the scale are rated as 1-5 scores:1:not at all acceptable,2:not very acceptable,3:somewhat acceptable, 4:totally acceptable and 5:I don't know.Total score of the dimension is calculated as the mean of recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:Total Score=(mean of the recoded items in the dimension minus1)divided by2\*100. LOCF was used as primary method of analysis. Data for participants without or with prior exposure has been presented. Baseline value is defined as last available value up to and including the Maintenance treatment. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Scores on a scale | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Without exposure, Week 24, n=319, 323 | 6.0 ± 27.96 | 4.0 ± 33.53 |
| Without exposure, Week 48, n=319, 324 | 6.9 ± 30.96 | 5.6 ± 31.77 |
| With exposure, Week 24, n=192, 194 | 0.3 ± 21.37 | -1.7 ± 21.79 |
| With exposure, Week 48, n=192, 194 | -0.1 ± 24.92 | -2.7 ± 24.25 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK Population comprises of all participants who received CAB and / or RPV and underwent PK sampling during the study and provide at least 1 non-missing CAB and / or RPV plasma concentration value (Non-quantifiable \[NQ\] values will be considered as non-missing values).
| Micrograms per milliliter | CAB LA Q8W | CAB LA Q4W |
|---|---|---|
| Pre-dose, Week 4, n=314, 513 | 5.1543 (4.8702 to 5.4550) | 4.0285 (3.8303 to 4.2369) |
| Pre-dose, Week 8, n=516, 513 | 1.7938 (1.7007 to 1.8920) | 1.9011 (1.7965 to 2.0119) |
| Pre-dose, Week 16, n=512, 514 | 1.5983 (1.5223 to 1.6781) | 2.3358 (2.2436 to 2.4317) |
| Pre-dose, Week 24, n=506, 510 | 1.5955 (1.5203 to 1.6744) | 2.5795 (2.4826 to 2.6802) |
| Pre-dose, Week 32, n=499, 498 | 1.7414 (1.6612 to 1.8254) | 2.8529 (2.7408 to 2.9696) |
| Pre-dose, Week 40, n=496, 497 | 1.7873 (1.7058 to 1.8727) | 2.9739 (2.8713 to 3.0801) |
| Pre-dose, Week 48, n=494, 486 | 1.6747 (1.6033 to 1.7493) | 2.7449 (2.6492 to 2.8441) |
Blood samples were collected at indicated time points for PK analysis of RPV LA.
| Nanograms per milliliters | RPV LA Q8W | RPV LA Q4W |
|---|---|---|
| Pre-dose, Week 4, n=315, 514 | 78.05 (73.32 to 83.09) | 78.60 (75.03 to 82.35) |
| Pre-dose, Week 8, n=515, 512 | 56.35 (53.73 to 59.09) | 57.95 (55.09 to 60.96) |
| Pre-dose, Week 16, n=512, 513 | 54.84 (52.55 to 57.22) | 68.12 (65.15 to 71.23) |
| Pre-dose, Week 24, n=506, 509 | 57.16 (54.77 to 59.66) | 75.76 (72.64 to 79.02) |
| Pre-dose, Week 32, n=498, 498 | 62.07 (59.54 to 64.71) | 85.76 (82.35 to 89.30) |
| Pre-dose, Week 40, n=497, 497 | 67.22 (64.58 to 69.97) | 89.49 (86.22 to 92.88) |
| Pre-dose, Week 48, n=495, 488 | 72.29 (69.50 to 75.19) | 97.22 (93.49 to 101.09) |
Blood samples were collected at indicated time points to analyze concentration in plasma for CAB LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
| Micrograms*hours per milliliter | CAB LA Q8W | CAB LA Q4W |
|---|---|---|
| Area Under the Curve (AUC) for CAB LA | 3756.03 (3648.02 to 3867.25) | 2449.75 (2378.56 to 2523.07) |
Blood samples were collected at indicated time points to analyze concentration in plasma for RPV LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
| Nanograms*hours per milliliter | RPV LA Q8W | RPV LA Q4W |
|---|---|---|
| AUC for RPV LA | 126467.59 (122284.26 to 130794.04) | 70306.62 (67814.64 to 72890.17) |
Blood samples were collected at indicated time points to analyze Cmax in plasma for CAB LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
| Micrograms per milliliter | CAB LA Q8W | CAB LA Q4W |
|---|---|---|
| Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable | 3.976 (3.839 to 4.117) | 4.277 (4.140 to 4.418) |
Blood samples were collected at indicated time points to analyze Cmax in plasma for RPV LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure.
| Nanograms per milliliter | RPV LA Q8W | RPV LA Q4W |
|---|---|---|
| Cmax in Plasma for RPV LA Evaluable | 133.062 (128.452 to 137.837) | 124.279 (119.825 to 128.899) |
Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter participant variability for pharmacokinetic parameters.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of intra participant variability for pharmacokinetic parameters.
No measurements were reported for this outcome.
Collected over Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAB LA + RPV LA Q8W | 1/522 (0.2%) | 27/522 (5.2%) | 429/522 (82.2%) |
| CAB LA + RPV LA Q4W | 0/523 (0%) | 19/523 (3.6%) | 427/523 (81.6%) |
| Event | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| PneumoniaInfections and infestations | 2/522 | 2/523 |
| AppendicitisInfections and infestations | 2/522 | 0/523 |
| HaemorrhoidsGastrointestinal disorders | 2/522 | 0/523 |
| Acute hepatitis BInfections and infestations | 1/522 | 1/523 |
| Abdominal abscessInfections and infestations | 1/522 | 0/523 |
| Anal abscessInfections and infestations | 1/522 | 0/523 |
| Epiglottitis obstructiveInfections and infestations | 1/522 | 0/523 |
| ErysipelasInfections and infestations | 1/522 | 0/523 |
| Gastroenteritis Escherichia coliInfections and infestations | 1/522 | 0/523 |
| Infectious pleural effusionInfections and infestations | 1/522 | 0/523 |
| Event | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
|---|---|---|
| Injection site painGeneral disorders | 371/522 | 363/523 |
| Injection site noduleGeneral disorders | 54/522 | 89/523 |
| NasopharyngitisInfections and infestations | 71/522 | 74/523 |
| Upper respiratory tract infectionInfections and infestations | 50/522 | 71/523 |
| PyrexiaGeneral disorders | 28/522 | 44/523 |
| Injection site indurationGeneral disorders | 41/522 | 39/523 |
| Injection site discomfortGeneral disorders | 36/522 | 41/523 |
| DiarrhoeaGastrointestinal disorders | 33/522 | 37/523 |
| HeadacheNervous system disorders | 35/522 | 36/523 |
| FatigueGeneral disorders | 13/522 | 33/523 |
| Age, Continuous(Years) | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W | Total |
|---|---|---|---|
| Mean | 42.7 ± 11.16 | 42.3 ± 10.58 | 42.5 ± 10.87 |
| Sex/Gender, Customized(Participants) | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W | Total |
|---|---|---|---|
| Sex at birth=Female | 137 | 143 | 280 |
| Sex at birth=Male | 385 | 380 | 765 |
| Sex/Gender, Customized(Participants) | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W | Total |
|---|---|---|---|
| Reported gender=Female | 142 | 146 | 288 |
| Reported gender=Male | 380 | 377 | 757 |
| Race/Ethnicity, Customized(Participants) | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W | Total |
|---|---|---|---|
| American Indian (AI) or Alaska Native (AN) | 17 | 11 | 28 |
| Asian-Central/South Asian Heritage (H) | 1 | 1 | 2 |
| Asian-East Asian H | 20 | 12 | 32 |
| Asian-Japanese H | 0 | 2 | 2 |
| Asian-South East Asian (SEA) H | 8 | 7 | 15 |
| Black or African American (AA) | 101 | 90 | 191 |
| Native Hawaiian (NH) or other Pacific Islander | 3 | 1 | 4 |
| White-Arabic/North African H | 2 | 4 | 6 |
| White-White/Caucasian/European (EU) H | 368 | 388 | 756 |
| White-Mixed White Race | 0 | 1 | 1 |
| Multiple-AI/AN and Black/AA/White/Caucasian/EU H | 1 | 1 | 2 |
| Multiple-AI/AN and NH/Other Pacific Islander | 1 | 0 | 1 |
| Multiple-SEA H and White/Caucasian/ EU H | 0 | 1 | 1 |
| Multiple-Black/AA and White-Arabic/North African H | 0 | 1 | 1 |
| Multiple-Black/AA and White/Caucasian/EU H | 0 | 3 | 3 |
Showing the first 100 of 119 sites across 13 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Oct 2017 to primary completion in Jun 2019, 19 months.
Results were first posted in Jun 2020, 1 year after primary completion.
Of 57 industry-sponsored phase 3 interventional studies under HIV Infections, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 30. This study's 19 months is below that.
Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 20 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cabotegravir · Rilpivirine