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CompletedNCT05896761Updated Sep 18, 2023Results posted

A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

A Phase 3 interventional study of Cabotegravir Injectable Suspension and Rilpivirine Injectable Suspension in Human Immunodeficiency Virus Type 1 (HIV-1), sponsored by ViiV Healthcare. Completed at 32 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Oct 2021, registered May 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS2M [A2M]) study (NCT03299049).

02

Conditions studied

  • Human Immunodeficiency Virus Type 1 (HIV-1)

Keywords

  • Cabotegravir
  • Efficacy
  • Human immunodeficiency virus
  • Pharmacokinetic
  • Rilpivirine
  • Safety
  • Tolerability
03

In context

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's enrollment of 118 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 265 studies on the registry; 16 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.

Browse ViiV Healthcare studies →All GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

Sub-study specific Inclusion Criteria:

  • Capable of giving sub-study specific informed consent.
  • Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 152 weeks while on the ATLAS2-M study. Any disruptions in dosing during ATLAS2-M must be discussed with the Medical Monitor for a final determination of eligibility into the sub-study.
  • Plasma HIV-1 RNA \<50 copies/mL at Sub-Study Screening.

Inclusion criteria detailed for the ATLAS-2M main study apply to the sub-study:

  • A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin [hCG] test) not lactating, and at least one of the following conditions applies:

    1. Non-reproductive potential defined as:

      • Pre-menopausal females with one of the following:

        i. Documented tubal ligation ii. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion iii. Hysterectomy iv. Documented Bilateral Oophorectomy

      • Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
    2. 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

Exclusion Criteria:

Sub-study specific Exclusion Criteria:

  • Participants with more than 1 plasma HIV-1 RNA measurement >=50 copies/mL to \<200 copies/mL (virologic blip) within 24 weeks prior to sub-study Screening visit.
  • Any Suspected Virologic Failure (HIV-RNA greater than [>]200 copies/mL as defined in during ATLAS-2M study.
  • Participants planning to require oral bridging during participation in the ATLAS-2M sub-study.
  • The participant has a tattoo or any dermatological condition overlying the thigh region which may interfere with interpretation of injection site reactions.
  • Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.

Exclusion criteria detailed for the ATLAS-2M main study apply to the sub-study:

  • Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
  • Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy, and Cluster of Differentiation 4 positive (CD4+) counts \<200 cells per microliter are not exclusionary.
  • Participants with moderate to severe hepatic impairment.
  • Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
  • Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment.
  • Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
  • Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • History of liver cirrhosis with or without hepatitis viral co-infection.
  • Ongoing or clinically relevant pancreatitis.
  • Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization.
  • Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
  • History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during PK sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
  • Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid lesser than or equal to (\<=)325 mg or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
  • Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
  • Participant has estimated creatine clearance \<50mL per minute per 1.73 square meter via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method.
  • Alanine aminotransferase (ALT) >=3 × upper limit of normal (ULN) at Screening.
  • Exposure to an experimental drug (with the exception of those in the ATLAS-2M study including CAB, CAB LA, and RPV, RPV LA) or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study.

  • Treatment with any of the following agents within 28 days of Screening:

    i. radiation therapy; ii. cytotoxic chemotherapeutic agents; iii. tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]); iv. anti-coagulation agents; v. Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons

  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
  • Use of medications which are associated with Torsade de Pointes.
  • Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    Participants receiving CAB LA 400 milligrams (mg) and RPV LA 600 mg

    Participants will receive an Intramuscular (IM) injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh injection phase. Participants will then return to the clinic 4 weeks later to receive their first IM gluteal injection (at Week 16) of CAB LA 400 mg and RPV LA 600 mg during the Return to Gluteal Injection Phase. The subsequent gluteal injection will occur at Week 20.

    Drug: Cabotegravir Injectable Suspension · Drug: Rilpivirine Injectable Suspension

  • Experimental
    Participants receiving CAB LA 600 mg and RPV LA 900 mg

    Participants will receive an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh injection phase. Participants will then return to the clinic 8 weeks later receive their first IM gluteal injection (at Week 16) of CAB LA 600mg and RPV LA 900 mg during the Return to Gluteal Injection phase. The subsequent gluteal injection will occur at Week 24.

    Drug: Cabotegravir Injectable Suspension · Drug: Rilpivirine Injectable Suspension

Interventions

  • DrugCabotegravir Injectable Suspension

    CAB LA injectable suspension is a sterile white to slightly pink suspension containing 200 milligrams per milliliter (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.

  • DrugRilpivirine Injectable Suspension

    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.

06

What researchers measure

Primary outcomes

  1. Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis.

    Time frame: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)

  2. Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)

  3. Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)

  4. Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)

  5. Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q8W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)

  6. Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q8W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)

  7. Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)

  8. Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)

  9. Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)

  10. Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)

  11. Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q4W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)

  12. Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q4W

    Blood samples were collected for PK analysis.

    Time frame: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)

Secondary outcomes

  1. Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase

    Severity of ISRs was analyzed using division of acquired immunodeficiency syndrome (DAIDS) grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. Data for number of participants with maximum grade or intensity for overall ISRs were reported.

    Time frame: Up to Week 16

  2. Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AESI was analyzed using DAIDS grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. Data for number of participants with common AESI based on maximum severity were reported.

    Time frame: Up to Week 16

  3. Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to ISRs and AESIs is presented.

    Time frame: Up to Week 16

  4. Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase

    Percentage of participants with plasma HIV-1 RNA \< 50 copies/mL was obtained using the FDA snapshot algorithm. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded off.

    Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16

  5. Percentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase

    Percentage of participants with plasma HIV 1 RNA \>= 50 copies/mL was obtained using the FDA snapshot algorithm. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded off.

    Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16

  6. Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL. Percentage of participants with protocol-defined CVF were reported.

    Time frame: Up to Week 16

  7. Number of Participants With Treatment Emergent Genotypic Resistance - Thigh Injection Phase

    Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with treatment emergent genotypic resistance were reported.

    Time frame: Up to Week 16

  8. Number of Participants With Treatment Emergent Phenotypic Resistance - Thigh Injection Phase

    Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with treatment emergent phenotypic resistance were reported.

    Time frame: Up to Week 16

  9. Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase

    A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections.

    Time frame: Day 1

  10. Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase

    A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections.

    Time frame: Week 8

  11. Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase

    A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections.

    Time frame: Week 12

  12. Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase

    A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections.

    Time frame: Study Week 16

  13. HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase

    HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicate dissatisfaction. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.

    Time frame: Baseline (Day 1) and Week 16

  14. HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm -Return to Gluteal Injection Phase

    HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 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 indicate a greater satisfaction and a lower score indicate dissatisfaction.

    Time frame: Study Week 24

  15. HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm -Return to Gluteal Injection Phase

    HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 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 indicate a greater satisfaction and a lower score indicate dissatisfaction.

    Time frame: Study Week 20

  16. Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase

    HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6(very satisfied) to 0(very dissatisfied).Higher scores represent greater satisfaction.Data was reported for each treatment satisfaction item based on(Item1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item5=convenience in finding treatment,Item6=flexibility in finding treatment,Item7=understanding HIV,Item8=extent to which the treatment fits in with lifestyle, Item9=recommendation of present treatment to someone else,Item10=continuation with present form of treatment,Item11=easy or difficult treatment,Item12=amount of discomfort/pain involved with present form of treatment).Baseline was latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.Change from Baseline was calculated by subtracting Baseline value from post-dose visit value.

    Time frame: Baseline (Day 1) and up to Week 16

  17. Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection

    HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on (Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment). Change from Study Week 16 to Study Week 24 was calculated by subtracting the Study Week 16 value from the Study Week 24 value.

    Time frame: Study Week 16 and Study Week 24

  18. Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase

    HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6(very satisfied) to 0(very dissatisfied).Higher scores represent greater satisfaction.Data was reported for each treatment satisfaction item based on(Item1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item5=convenience in finding treatment,Item6=flexibility in finding treatment,Item7=understanding HIV,Item8=extent to which the treatment fits in with lifestyle, Item9=recommendation of present treatment to someone else,Item10=continuation with present form of treatment,Item11=easy or difficult treatment,Item12=amount of discomfort/pain involved with present form of treatment).Change from Study Week 16 to Study Week 20 was calculated by subtracting the Study Week 16 value from the Study Week 20 value.

    Time frame: Study Week 16 and Study Week 20

  19. HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase

    HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. 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.

    Time frame: Up to Week 16

  20. HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase

    HIVTSQc is a 12-item questionnaire to measure treatment satisfaction in HIV participants. Individual items were rated as +3 (much more satisfied) to -3 (much less satisfied). Higher the score, greater the improvement in satisfaction with each aspect of treatment and lower the score, greater the deterioration in satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on (Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment).

    Time frame: Up to Week 16

  21. Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm

    A preference questionnaire was used to assess participant's preference for the thigh injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Injections in the buttock, Injections in the thigh and No preference.

    Time frame: Up to Study Week 24

  22. Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm

    A preference questionnaire was used to assess participant's preference for the thigh injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Injections in the buttock, Injections in the thigh, Other and No preference.

    Time frame: Up to Study Week 20

07

Results

Posted Sep 18, 2023

Participant flow

This is a sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting (LA) in Human Immunodeficiency Viruses (HIV)-infected participants currently enrolled in the Antiretroviral Therapy as Long- Acting Suppression every 2 Months (ATLAS2M \[A2M\]) study (NCT03299049).

Thigh Injection Phase (Up to Week 16)
Participant flow — Thigh Injection Phase (Up to Week 16)
MilestoneCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Started5464
Completed5161
Not completed33
Withdrew: Adverse event10
Withdrew: Withdrawal by subject23
Return to Glu Inj Phase (Weeks 16 to 24)
Participant flow — Return to Glu Inj Phase (Weeks 16 to 24)
MilestoneCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Started5161
Completed5161
Not completed00

Outcome measures

PrimaryConcentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis.

Time frame:
Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Reported as:
Geometric mean · Micrograms per milliliter
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W
Micrograms per milliliterCAB+RPV Q8W First Thigh InjectionCAB+RPV Q8W Last Thigh InjectionCAB+RPV Q8W Pre-Thigh Gluteal Injection
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W1.67 ± 69.31.61 ± 55.51.81 ± 51.6
Statistical analysis
  • CAB+RPV Q8W First Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 0.926 · 90% CI 0.831 to 1.03
  • CAB+RPV Q8W Last Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 0.929 · 90% CI 0.816 to 1.06
PrimaryConcentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W

Blood samples were collected for PK analysis.

Time frame:
Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Reported as:
Geometric mean · Nanograms per milliliter
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W
Nanograms per milliliterCAB+RPV Q8W First Thigh InjectionCAB+RPV Q8W Last Thigh InjectionCAB+RPV Q8W Pre-Thigh Gluteal Injection
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W103 ± 49.7117 ± 54.1104 ± 41.5
Statistical analysis
  • CAB+RPV Q8W First Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.06 · 90% CI 0.966 to 1.17
  • CAB+RPV Q8W Last Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.18 · 90% CI 1.07 to 1.29
PrimaryMaximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W

Blood samples were collected for PK analysis.

Time frame:
Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Reported as:
Geometric mean · Micrograms per milliliter
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W
Micrograms per milliliterCAB+RPV Q8W First Thigh InjectionCAB+RPV Q8W Last Thigh InjectionCAB+RPV Q8W Pre-Thigh Gluteal Injection
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W4.52 ± 37.73.70 ± 40.83.36 ± 41.4
Statistical analysis
  • CAB+RPV Q8W First Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.35 · 90% CI 1.22 to 1.49
  • CAB+RPV Q8W Last Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.10 · 90% CI 0.975 to 1.24
PrimaryMaximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W

Blood samples were collected for PK analysis.

Time frame:
Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Reported as:
Geometric mean · Nanograms per milliliter
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W
Nanograms per milliliterCAB+RPV Q8W First Thigh InjectionCAB+RPV Q8W Last Thigh InjectionCAB+RPV Q8W Pre-Thigh Gluteal Injection
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W184 ± 33.9172 ± 47.4146 ± 56.5
Statistical analysis
  • CAB+RPV Q8W First Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.26 · 90% CI 1.12 to 1.40
  • CAB+RPV Q8W Last Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.18 · 90% CI 1.09 to 1.28
PrimaryArea Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q8W

Blood samples were collected for PK analysis.

Time frame:
Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Reported as:
Geometric mean · Hour*microgram/milliliter
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q8W
Hour*microgram/milliliterCAB+RPV Q8W First Thigh InjectionCAB+RPV Q8W Last Thigh InjectionCAB+RPV Q8W Pre-Thigh Gluteal Injection
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q8W4038 ± 34.63384 ± 36.63344 ± 32.9
Statistical analysis
  • CAB+RPV Q8W First Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.21 · 90% CI 1.13 to 1.30
  • CAB+RPV Q8W Last Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.09 · 90% CI 1.00 to 1.20
PrimaryArea Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q8W

Blood samples were collected for PK analysis.

Time frame:
Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Reported as:
Geometric mean · Hour*nanogram/milliliter
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q8W
Hour*nanogram/milliliterCAB+RPV Q8W First Thigh InjectionCAB+RPV Q8W Last Thigh InjectionCAB+RPV Q8W Pre-Thigh Gluteal Injection
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q8W179483 ± 33.8190641 ± 50.4162046 ± 36.7
Statistical analysis
  • CAB+RPV Q8W First Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.15 · 90% CI 1.07 to 1.23
  • CAB+RPV Q8W Last Thigh Injection vs CAB+RPV Q8W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.29 · 90% CI 1.20 to 1.38
PrimaryConcentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W

Blood samples were collected for PK analysis.

Time frame:
Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Reported as:
Geometric mean · Micrograms per milliliter
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W
Micrograms per milliliterCAB+RPV Q4W First Thigh InjectionCAB+RPV Q4W Last Thigh InjectionCAB+RPV Q4W Pre-Thigh Gluteal Injection
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W3.34 ± 34.63.00 ± 37.82.94 ± 38.9
Statistical analysis
  • CAB+RPV Q4W First Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.16 · 90% CI 1.08 to 1.25
  • CAB+RPV Q4W Last Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 0.983 · 90% CI 0.890 to 1.09
PrimaryConcentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W

Blood samples were collected for PK analysis.

Time frame:
Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Reported as:
Geometric mean · Nanograms per milliliter
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W
Nanograms per milliliterCAB+RPV Q4W First Thigh InjectionCAB+RPV Q4W Last Thigh InjectionCAB+RPV Q4W Pre-Thigh Gluteal Injection
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W170 ± 35.2171 ± 39.8162 ± 37.6
Statistical analysis
  • CAB+RPV Q4W First Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.06 · 90% CI 0.991 to 1.13
  • CAB+RPV Q4W Last Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.04 · 90% CI 0.974 to 1.12
PrimaryMaximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W

Blood samples were collected for PK analysis.

Time frame:
Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Reported as:
Geometric mean · Micrograms per milliliter
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W
Micrograms per milliliterCAB+RPV Q4W First Thigh InjectionCAB+RPV Q4W Last Thigh InjectionCAB+RPV Q4W Pre-Thigh Gluteal Injection
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W4.65 ± 38.34.09 ± 35.63.95 ± 35.8
Statistical analysis
  • CAB+RPV Q4W First Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.18 · 90% CI 1.11 to 1.25
  • CAB+RPV Q4W Last Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.06 · 90% CI 0.989 to 1.14
PrimaryMaximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W

Blood samples were collected for PK analysis.

Time frame:
Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Reported as:
Geometric mean · Nanograms per milliliter
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W
Nanograms per milliliterCAB+RPV Q4W First Thigh InjectionCAB+RPV Q4W Last Thigh InjectionCAB+RPV Q4W Pre-Thigh Gluteal Injection
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W210 ± 34.9205 ± 34.8197 ± 33.8
Statistical analysis
  • CAB+RPV Q4W First Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.08 · 90% CI 1.03 to 1.12
  • CAB+RPV Q4W Last Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.04 · 90% CI 0.997 to 1.08
PrimaryArea Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q4W

Blood samples were collected for PK analysis.

Time frame:
Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Reported as:
Geometric mean · Hours*micrograms per milliliter
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q4W
Hours*micrograms per milliliterCAB+RPV Q4W First Thigh InjectionCAB+RPV Q4W Last Thigh InjectionCAB+RPV Q4W Pre-Thigh Gluteal Injection
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q4W2558 ± 34.42379 ± 34.82275 ± 35.1
Statistical analysis
  • CAB+RPV Q4W First Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.13 · 90% CI 1.08 to 1.19
  • CAB+RPV Q4W Last Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.04 · 90% CI 0.97 to 1.11
PrimaryArea Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q4W

Blood samples were collected for PK analysis.

Time frame:
Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Reported as:
Geometric mean · Hour*nanogram per milliliter
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q4W
Hour*nanogram per milliliterCAB+RPV Q4W First Thigh InjectionCAB+RPV Q4W Last Thigh InjectionCAB+RPV Q4W Pre-Thigh Gluteal Injection
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q4W120963 ± 32.6123197 ± 33.6115202 ± 33.9
Statistical analysis
  • CAB+RPV Q4W First Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.06 · 90% CI 1.02 to 1.11
  • CAB+RPV Q4W Last Thigh Injection vs CAB+RPV Q4W Pre-Thigh Gluteal Injection · Ratio of geometric least square mean: 1.06 · 90% CI 1.01 to 1.11
SecondaryNumber of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase

Severity of ISRs was analyzed using division of acquired immunodeficiency syndrome (DAIDS) grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. Data for number of participants with maximum grade or intensity for overall ISRs were reported.

Time frame:
Up to Week 16
Reported as:
Count of participants · Participants
Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase
ParticipantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Mild or Grade 11827
Moderate or Grade 21612
Severe or Grade 346
Potentially Life-Threatening or Grade 400
Death or Grade 500
SecondaryNumber of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AESI was analyzed using DAIDS grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. Data for number of participants with common AESI based on maximum severity were reported.

Time frame:
Up to Week 16
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase
ParticipantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Mild or Grade 11827
Moderate or Grade 21612
Severe or Grade 346
Potentially Life-Threatening or Grade 400
Death or Grade 500
SecondaryNumber of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to ISRs and AESIs is presented.

Time frame:
Up to Week 16
Reported as:
Count of participants · Participants
Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase
ParticipantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Discontinuations due to AESI10
Discontinuations due to ISR10
SecondaryPercentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase

Percentage of participants with plasma HIV-1 RNA \< 50 copies/mL was obtained using the FDA snapshot algorithm. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded off.

Time frame:
Baseline (Day 1) and at Weeks 4, 8, 12, 16
Reported as:
Number · Percentage of participants
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase
Percentage of participantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Baseline (Day 1)100 (93 to 100)98 (95 to 100)
Week 4100 (93 to 100)98 (95 to 100)
Week 896 (91 to 100)97 (93 to 100)
Week 1294 (88 to 100)95 (90 to 100)
Week 1694 (88 to 100)95 (90 to 100)
SecondaryPercentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase

Percentage of participants with plasma HIV 1 RNA \>= 50 copies/mL was obtained using the FDA snapshot algorithm. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded off.

Time frame:
Baseline (Day 1) and at Weeks 4, 8, 12, 16
Reported as:
Number · Percentage of participants
Percentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase
Percentage of participantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Baseline (Day 1)0 (0.0 to 6.6)1.6 (0.0 to 4.6)
Week 40 (0.0 to 6.6)0 (0.0 to 5.6)
Week 80 (0.0 to 6.6)0 (0.0 to 5.6)
Week 120 (0.0 to 6.6)0 (0.0 to 5.6)
Week 160 (0.0 to 6.6)0 (0.0 to 5.6)
SecondaryPercentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL. Percentage of participants with protocol-defined CVF were reported.

Time frame:
Up to Week 16
Reported as:
Number · Percentage of participants
Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase
Percentage of participantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase00
SecondaryNumber of Participants With Treatment Emergent Genotypic Resistance - Thigh Injection Phase

Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with treatment emergent genotypic resistance were reported.

Time frame:
Up to Week 16

No measurements were reported for this outcome.

SecondaryNumber of Participants With Treatment Emergent Phenotypic Resistance - Thigh Injection Phase

Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with treatment emergent phenotypic resistance were reported.

Time frame:
Up to Week 16

No measurements were reported for this outcome.

SecondaryNumber of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase

A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
ParticipantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Score 01421
Score 11316
Score 276
Score 367
Score 454
Score 544
Score 632
Score 703
Score 810
Score 910
Score 1001
SecondaryNumber of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase

A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections.

Time frame:
Week 8
Reported as:
Count of participants · Participants
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
ParticipantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)
Score 015
Score 111
Score 29
Score 35
Score 41
Score 53
Score 62
Score 72
Score 81
Score 91
Score 101
SecondaryNumber of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase

A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
ParticipantsCAB LA 400 mg + RPV LA 600 mg (Q4W)
Score 020
Score 112
Score 27
Score 34
Score 49
Score 54
Score 61
Score 71
Score 80
Score 92
Score 101
SecondaryNumber of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase

A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections.

Time frame:
Study Week 16
Reported as:
Count of participants · Participants
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
ParticipantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Score 01422
Score 1811
Score 2106
Score 368
Score 453
Score 512
Score 655
Score 710
Score 803
Score 911
Score 1000
SecondaryHIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase

HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicate dissatisfaction. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.

Time frame:
Baseline (Day 1) and Week 16
Reported as:
Mean · Scores on a scale
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase
Scores on a scaleCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Baseline (Day 1)63.85 ± 3.37864.03 ± 3.376
Week 1661.69 ± 6.91261.74 ± 8.786
SecondaryHIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm -Return to Gluteal Injection Phase

HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 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 indicate a greater satisfaction and a lower score indicate dissatisfaction.

Time frame:
Study Week 24
Reported as:
Mean · Scores on a scale
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm -Return to Gluteal Injection Phase
Scores on a scaleCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm -Return to Gluteal Injection Phase63.78 ± 3.743
SecondaryHIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm -Return to Gluteal Injection Phase

HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 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 indicate a greater satisfaction and a lower score indicate dissatisfaction.

Time frame:
Study Week 20
Reported as:
Mean · Scores on a scale
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm -Return to Gluteal Injection Phase
Scores on a scaleCAB LA 400 mg + RPV LA 600 mg (Q4W)
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm -Return to Gluteal Injection Phase63.25 ± 4.911
SecondaryChange From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase

HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6(very satisfied) to 0(very dissatisfied).Higher scores represent greater satisfaction.Data was reported for each treatment satisfaction item based on(Item1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item5=convenience in finding treatment,Item6=flexibility in finding treatment,Item7=understanding HIV,Item8=extent to which the treatment fits in with lifestyle, Item9=recommendation of present treatment to someone else,Item10=continuation with present form of treatment,Item11=easy or difficult treatment,Item12=amount of discomfort/pain involved with present form of treatment).Baseline was latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.Change from Baseline was calculated by subtracting Baseline value from post-dose visit value.

Time frame:
Baseline (Day 1) and up to Week 16
Reported as:
Mean · Scores on a scale
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Scores on a scaleCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Item 1-0.3 ± 1.37-0.3 ± 1.09
Item 2-0.1 ± 0.270.0 ± 0.38
Item 3-0.7 ± 1.32-0.2 ± 0.92
Item 4-0.2 ± 0.81-0.2 ± 0.96
Item 5-0.1 ± 0.63-0.2 ± 0.87
Item 60.0 ± 0.88-0.3 ± 0.86
Item 7-0.1 ± 0.73-0.1 ± 0.64
Item 8-0.1 ± 0.95-0.1 ± 0.84
Item 9-0.2 ± 0.92-0.1 ± 0.83
Item 10-0.3 ± 1.11-0.3 ± 1.12
Item 11-0.1 ± 0.83-0.4 ± 1.02
Item 12-0.7 ± 1.87-0.5 ± 1.29
SecondaryChange From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection

HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on (Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment). Change from Study Week 16 to Study Week 24 was calculated by subtracting the Study Week 16 value from the Study Week 24 value.

Time frame:
Study Week 16 and Study Week 24
Reported as:
Mean · Scores on a scale
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Scores on a scaleCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)
Item 10.3 ± 1.16
Item 20.0 ± 0.34
Item 30.5 ± 1.19
Item 40.2 ± 0.80
Item 50.1 ± 0.59
Item 60.3 ± 0.56
Item 70.0 ± 0.40
Item 80.2 ± 0.86
Item 90.2 ± 0.88
Item 100.2 ± 1.14
Item 110.1 ± 0.84
Item 120.7 ± 1.47
SecondaryChange From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase

HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6(very satisfied) to 0(very dissatisfied).Higher scores represent greater satisfaction.Data was reported for each treatment satisfaction item based on(Item1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item5=convenience in finding treatment,Item6=flexibility in finding treatment,Item7=understanding HIV,Item8=extent to which the treatment fits in with lifestyle, Item9=recommendation of present treatment to someone else,Item10=continuation with present form of treatment,Item11=easy or difficult treatment,Item12=amount of discomfort/pain involved with present form of treatment).Change from Study Week 16 to Study Week 20 was calculated by subtracting the Study Week 16 value from the Study Week 20 value.

Time frame:
Study Week 16 and Study Week 20
Reported as:
Mean · Scores on a scale
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Scores on a scaleCAB LA 400 mg + RPV LA 600 mg (Q4W)
Item 10.2 ± 0.73
Item 20.1 ± 0.31
Item 30.3 ± 0.85
Item 40.1 ± 0.60
Item 50.1 ± 0.69
Item 60.1 ± 0.73
Item 70.0 ± 0.64
Item 80.0 ± 0.52
Item 90.1 ± 0.69
Item 100.2 ± 0.80
Item 110.3 ± 0.79
Item 120.4 ± 1.02
SecondaryHIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase

HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. 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.

Time frame:
Up to Week 16
Reported as:
Mean · Scores on a scale
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase
Scores on a scaleCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase17.8 ± 16.0219.7 ± 15.45
SecondaryHIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase

HIVTSQc is a 12-item questionnaire to measure treatment satisfaction in HIV participants. Individual items were rated as +3 (much more satisfied) to -3 (much less satisfied). Higher the score, greater the improvement in satisfaction with each aspect of treatment and lower the score, greater the deterioration in satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on (Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment).

Time frame:
Up to Week 16
Reported as:
Mean · Scores on a scale
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Scores on a scaleCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)
Item 11.5 ± 1.841.7 ± 1.71
Item 21.8 ± 1.421.9 ± 1.42
Item 31.3 ± 1.921.5 ± 1.70
Item 41.5 ± 1.741.8 ± 1.48
Item 51.7 ± 1.531.6 ± 1.66
Item 61.6 ± 1.371.7 ± 1.50
Item 71.7 ± 1.442.0 ± 1.35
Item 81.7 ± 1.552.0 ± 1.47
Item 91.7 ± 1.802.0 ± 1.57
Item 101.5 ± 2.001.9 ± 1.71
Item 111.6 ± 1.691.7 ± 1.65
Item 121.0 ± 2.141.4 ± 1.74
SecondaryNumber of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm

A preference questionnaire was used to assess participant's preference for the thigh injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Injections in the buttock, Injections in the thigh and No preference.

Time frame:
Up to Study Week 24
Reported as:
Count of participants · Participants
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm
ParticipantsCAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)
Injections in the buttock29
Injections in the thigh17
No preference5
SecondaryNumber of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm

A preference questionnaire was used to assess participant's preference for the thigh injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Injections in the buttock, Injections in the thigh, Other and No preference.

Time frame:
Up to Study Week 20
Reported as:
Count of participants · Participants
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm
ParticipantsCAB LA 400 mg + RPV LA 600 mg (Q4W)
Injections in the buttock39
Injections in the thigh17
No preference5

Adverse events

Collected over All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CAB LA 600 mg + RPV LA 900 mg Q8W-Thigh Injection Phase0/54 (0%)0/54 (0%)38/54 (70.4%)
CAB LA 400 mg + RPV LA 600 mg (Q4W) -Thigh Injection Phase0/64 (0%)0/64 (0%)46/64 (71.9%)
CAB LA 600 mg + RPV LA 900 mg Q8W- Gluteal Injection Phase0/51 (0%)1/51 (2%)6/51 (11.8%)
CAB LA 400 mg + RPV LA 600 mg (Q4W) - Gluteal Injection Phase0/61 (0%)0/61 (0%)11/61 (18%)
Most frequent serious events
Most frequent serious events
EventCAB LA 600 mg + RPV LA 900 mg Q8W-Thigh Injection PhaseCAB LA 400 mg + RPV LA 600 mg (Q4W) -Thigh Injection PhaseCAB LA 600 mg + RPV LA 900 mg Q8W- Gluteal Injection PhaseCAB LA 400 mg + RPV LA 600 mg (Q4W) - Gluteal Injection Phase
COVID-19Infections and infestations0/540/641/510/61
Most frequent other events
Most frequent other events
EventCAB LA 600 mg + RPV LA 900 mg Q8W-Thigh Injection PhaseCAB LA 400 mg + RPV LA 600 mg (Q4W) -Thigh Injection PhaseCAB LA 600 mg + RPV LA 900 mg Q8W- Gluteal Injection PhaseCAB LA 400 mg + RPV LA 600 mg (Q4W) - Gluteal Injection Phase
Injection site painGeneral disorders38/5443/643/519/61
COVID-19Infections and infestations6/545/643/513/61
Injection site discomfortGeneral disorders3/545/640/510/61
Injection site swellingGeneral disorders2/545/640/510/61
FatigueGeneral disorders4/541/640/510/61
PyrexiaGeneral disorders3/541/640/510/61
HeadacheNervous system disorders3/541/640/510/61
DiarrhoeaGastrointestinal disorders3/540/640/510/61
CoughRespiratory, thoracic and mediastinal disorders3/540/640/510/61

Baseline characteristics

Age, Continuous
Age, Continuous(Years)CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)Total
Mean48.6 ± 12.5646.6 ± 10.6047.5 ± 11.53
Sex: Female, Male
Sex: Female, Male(Participants)CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)Total
Female192645
Male353873
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)CAB LA 400 mg + RPV LA 600 mg (Q4W)Total
AMERICAN INDIAN OR ALASKA NATIVE011
ASIAN - JAPANESE HERITAGE011
BLACK OR AFRICAN AMERICAN11718
WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE435497
MULTIPLE011
08

Study locations

32 sites
  • GSK Investigational Site
    Bakersfield, California 93301, United States
  • GSK Investigational Site
    Fort Lauderdale, Florida 33316, United States
  • GSK Investigational Site
    Ft. Pierce, Florida 34982, United States
  • GSK Investigational Site
    Sarasota, Florida 34237, United States
  • GSK Investigational Site
    Vero Beach, Florida 32690, United States
  • GSK Investigational Site
    Macon, Georgia 31201, United States
  • GSK Investigational Site
    Omaha, Nebraska 68198, United States
  • GSK Investigational Site
    New York, New York 10029, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15212, United States
  • GSK Investigational Site
    Lynchburg, Virginia 24501, United States
  • GSK Investigational Site
    Ciudad de Buenos Aires, Buenos Aires C1202ABB, Argentina
  • GSK Investigational Site
    Rosario, Santa Fe Province S2000PBJ, Argentina
  • GSK Investigational Site
    Ottawa, Ontario K1H 8L6, Canada
  • GSK Investigational Site
    Regina, Saskatchewan S4P 0W5, Canada
  • GSK Investigational Site
    Frankfurt am Main, Hesse 60596, Germany
  • GSK Investigational Site
    Hanover, Lower Saxony 30625, Germany
  • GSK Investigational Site
    Berlin, 10787, Germany
  • GSK Investigational Site
    Hamburg, 20246, Germany
  • GSK Investigational Site
    Milan, Lombardy 20157, Italy
  • GSK Investigational Site
    Badalona, 08916, Spain
  • GSK Investigational Site
    Barcelona, 08035, Spain
  • GSK Investigational Site
    Elche (Alicante), 03203, Spain
  • GSK Investigational Site
    Madrid, 28034, Spain
  • GSK Investigational Site
    Madrid, 28041, Spain
  • GSK Investigational Site
    Madrid, 28046, Spain
  • GSK Investigational Site
    Málaga, 29010, Spain
  • GSK Investigational Site
    Santiago de Compostela, 15706, Spain
  • GSK Investigational Site
    Seville, 41013, Spain
  • GSK Investigational Site
    Valencia, 46014, Spain
  • GSK Investigational Site
    Vigo, 36312, Spain
  • GSK Investigational Site
    Gothenburg, SE-416 85, Sweden
  • GSK Investigational Site
    Stockholm, SE-14186, Sweden
09

References and documents

Study documents

  • Study protocol · Aug 11, 2021
  • Statistical analysis plan · Sep 23, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Data sharing details ↗ · www.gsk.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Aug 2022, 9 months.

Results were first posted in Sep 2023, 1 year after primary completion.

Of 37 industry-sponsored phase 3 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 27. This study's 9 months is below that.

Counting every sponsor, half of 65 studies reached it within 25 months; a quarter within 20 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2023
First posted
Jun 9, 2023
StartActual
Oct 28, 2021
Primary completionActual
Aug 23, 2022
CompletionActual
Aug 23, 2022
Results first posted
Sep 18, 2023
Last update
Sep 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05896761
Lead sponsor
ViiV Healthcare
Collaborators
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Jun 9, 2023
Start date
Oct 28, 2021
Primary completion
Aug 23, 2022
Completion
Aug 23, 2022
Results posted
Sep 18, 2023
Last update
Sep 18, 2023

Study contacts

GSK Clinical Trials
study director · ViiV Healthcare

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Cabotegravir · Rilpivirine

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