Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

March 5, 2026 updated by: ViiV Healthcare

A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA <50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

631

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, 460-0001
        • GSK Investigational Site
      • Osaka, Japan, 540-0006
        • GSK Investigational Site
      • Tokyo, Japan, 162-8655
        • GSK Investigational Site
  • Russia
      • Kazan', Russia, 420061
        • GSK Investigational Site
      • Kemerovo, Russia, 650056
        • GSK Investigational Site
      • Krasnodar, Russia, 350015
        • GSK Investigational Site
      • Lipetsk, Russia, 398043
        • GSK Investigational Site
      • Moscow, Russia, 115035
        • GSK Investigational Site
      • Oryol, Russia, 302040
        • GSK Investigational Site
      • Saint Petersburg, Russia, 193167
        • GSK Investigational Site
      • Saint Petersburg, Russia, 196645
        • GSK Investigational Site
      • Saint Petersburg, Russia, 190020
        • GSK Investigational Site
      • Saratov, Russia, 410009
        • GSK Investigational Site
      • Smolensk, Russia, 214006
        • GSK Investigational Site
      • Toliyatti, Russia, 445846
        • GSK Investigational Site
      • Yekaterinburg, Russia, 620102
        • GSK Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • GSK Investigational Site
      • Cape Town, South Africa, 7925
        • GSK Investigational Site
      • Durban, South Africa, 4091
        • GSK Investigational Site
      • Durban, South Africa, 4052
        • GSK Investigational Site
      • Johannesburg, South Africa, 2113
        • GSK Investigational Site
      • Middelburg, South Africa, 1055
        • GSK Investigational Site
      • Pretoria, South Africa, 0087
        • GSK Investigational Site
  • Spain
      • Ferrol, Spain, 15405
        • GSK Investigational Site
      • Granada, Spain, 18016
        • GSK Investigational Site
      • La Laguna Santa Cruz, Spain, 38320
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Murcia, Spain, 30003
        • GSK Investigational Site
      • San SebastiAn de Los Rey, Spain, 28702
        • GSK Investigational Site
      • Santa Cruz de Tenerife, Spain, 38010
        • GSK Investigational Site
      • Santander, Spain, 39008
        • GSK Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • GSK Investigational Site
      • Leeds Yorkshire, United Kingdom, LS1 3EX
        • GSK Investigational Site
      • London, United Kingdom, E1 1BB
        • GSK Investigational Site
  • United States
    • California
      • Long Beach, California, United States, 90813
        • GSK Investigational Site
      • Los Angeles, California, United States, 90019
        • GSK Investigational Site
      • Los Angeles, California, United States, 90027
        • GSK Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30912-3130
        • GSK Investigational Site
      • Macon, Georgia, United States, 31201
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • GSK Investigational Site
      • Bellaire, Texas, United States, 77401
        • GSK Investigational Site
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: - HIV-1 infected, ART-naive men or women aged 18 years or greater at the time of signing the informed consent. - HIV-1 infection as documented by Screening plasma HIV-1 RNA >=1000 c/mL; - Antiretroviral-naive (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary. - Female Participants: A female participant is eligible to participate if she is not pregnant at Screening and first day of Induction Phase (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential 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; 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 enrolment. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner. - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. - In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria: - Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study. - Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current cluster of differentiation4+ (CD4+) cell count <200 cells/ cubic millimeter (mm^3) are not exclusionary. - Participants with known moderate to severe hepatic impairment. - Any pre-existing physical or mental condition (including substance abuse 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 enrolment 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 enrolment. - Participant who, in the investigator's judgment, poses a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. - The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. - Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti HBc), Hepatitis B surface antibody (anti-HBs) and HBV dioxyribose nucleic acid (DNA) as follows: Participants positive for HBsAg are excluded; Participants 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. - Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment prior to Week 48 of the Maintenance Phase must be excluded. HCV treatment on study may be permitted post Week 48, following consultation with the Medical Monitor. Participants with HCV co-infection will be allowed entry into Phase 3 studies if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, HCV is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on participants with HCV co-infection at screening should include results from any liver biopsy, fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. In the event that recent biopsy or imaging data is not available or is inconclusive, the Fib-4 score will be used to verify eligibility. A Fib-4 score > 3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation. Fibrosis 4 Score Formula: (Age x AST)/(Platelets x [square root of ALT]). - Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), 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. - All participants will be screened for syphilis (rapid plasma reagin [RPR]). Participants with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Participants with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis. - Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study Medical Monitor for inclusion of the participant prior to enrollment. - Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug 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 pharmacokinetic sampling (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. - Alanine aminotransferase (ALT) >=3 times upper limit normal (ULN). - 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. - Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product (IP). - Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; tuberculosis (TB) therapy, with the exception of treatment of latent TB with isoniazid; Immunomodulators that alter immune responses (such as chronic systemic corticosteroids, interleukins, or interferons). Note: Participants using short-term (e.g. =<21 day) systemic corticosteroid treatment, topical, inhaled or intranasal corticosteroids are eligible for enrollment. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. - Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of the first dose of IP. - Use of medications which are associated with Torsades de Pointes - Any evidence of primary resistance to non-nuclease reverse transcriptase inhibitors (NNRTIs) (except for K103N which is allowed), or any known resistance to INIs from historical resistance test results. Note: re-tests of Screening genotypes are allowed only at the discretion of the study virologist. - Participants who are HLA-B*5701 positive and are unable to use an nuclease reverse transcriptase inhibitors (NRTI) backbone that does not contain abacavir (participants who are HLA-B*5701 positive may be enrolled if they use a NRTI backbone that does not contain abacavir; HLA-B*5701 positive participants may be excluded from the study if local provision of an alternate NRTI backbone is not possible). - 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 creatinine clearance <50 mL/min/1.73m^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. - Participants who are currently participating in or anticipate to be selected for any other interventional study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAB LA + RPV LA every 4 weeks
After Induction Phase with ABC/DTG/3TC (or DTG + two NRTIs), eligible participants will receive oral CAB 30 mg + RPV 25 mg once daily for approximately four weeks. At visit Week 4b subjects will receive an initial loading dose of CAB LA (600 mg) and RPV LA (900 mg) at Week 4b. From Week 8 onwards, subjects will receive CAB LA (400 mg) + RPV LA (600 mg) injections every 4 weeks.
Drug: Rilpivirine - Injectable Suspension (RPV LA)
It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
Drug: Cabotegravir (CAB) tablet
It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat.
Drug: Rilpivirine (RPV) tablet
It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with "TMC" and the other side with "25". Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose.
Drug: Cabotegravir - Injectable Suspension (CAB LA)
It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection.
Active Comparator: ABC / DTG / 3TC (600 mg/50mg/300mg) once daily
After the Induction Phase with ABC/DTG/3TC (or DTG + two NRTIs), eligible participants will continue to receive oral ABC/DTG/3TC (or DTG + two NRTIs) initiated during the Induction Phase for 100 weeks. At the end of the Maintenance Phase, eligible participants receiving ABC/DTG/3TC (or DTG + two NRTIs) have the option to continue in the study by switching to CAB LA + RPV LA in the Extension Phase. These participants will transition to LA dosing at either Week 100 (direct to inject) or Week 104b (if using optional oral lead-in with CAB 30 mg + RPV 25 mg once daily).
Drug: ABC/DTG/3TC STR - Tablet
It is a purple, biconvex, oval, tablet debossed with "572 Tri" on one side, film-coated tablet contains abacavir sulphate equivalent to 600 mg of abacavir, dolutegravir sodium equivalent to 50 mg dolutegravir, and 300 mg of lamivudine. The inactive ABC/DTG/3TC tablet ingredients include D-mannitol, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
Drug: DTG Tablet
It is a yellow, round, biconvex, 50 mg film-coated tablet debossed with "SV 572" on one side and "50" on the other side. Each tablet of DTG also contains the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48
Time Frame: Week 48
Percentage of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event).
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Baseline (Day 1) and at Weeks 4, 24 and 48
Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41
Time Frame: Week 41- 1 Week post dose
Blood samples will be collected at indicated time points for PK analysis of CAB LA.
Week 41- 1 Week post dose
Cmax in Plasma for RPV LA Evaluable at Week 41
Time Frame: Week 41- 1 Week post dose
Blood samples will be collected at indicated time points for PK analysis of RPV LA.
Week 41- 1 Week post dose
Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48
Time Frame: Week 48
Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders.
Week 48
Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48
Time Frame: Week 48
Percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC
Week 48
Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase
Time Frame: Week 48
The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL.
Week 48
Absolute Values for Plasma HIV-1 RNA at Week 48
Time Frame: Week 48
Plasma for quantitative HIV-1 RNA were collected at indicated time points. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
Week 48
Change From Baseline Values for Plasma HIV-1 RNA at Week 48
Time Frame: Baseline (Day 1) and at Week 48
Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline.
Baseline (Day 1) and at Week 48
Absolute Values for CD4+ Lymphocyte Count at Week 48
Time Frame: Week 48
Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC
Week 48
Change From Baseline Values for CD4+ Lymphocyte Count at Week 48
Time Frame: Baseline (Day 1) and Week 48
Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance Baseline value.
Baseline (Day 1) and Week 48
Number of Participants With Disease Progression
Time Frame: Day 1 up to an average of 59 weeks
Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria).
Day 1 up to an average of 59 weeks
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to an average of 59 Weeks
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is 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 judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in >=5% of participants within any arm is reported
Day 1 up to an average of 59 Weeks
Number of Participants With Severity of Adverse Events
Time Frame: Up to Week 48
Severity of adverse events (AEs) were defined as per The Division of acquired immuno deficiency syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm.
Up to Week 48
Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK)
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated timepoints.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance.
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Absolute Values for Fasting Lipid Panel Overtime Including Week 48
Time Frame: Baseline (Day 1) and at Week 48
Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.
Baseline (Day 1) and at Week 48
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 24 and 48
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to DAIDS scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented.
Baseline (Day 1) and at Weeks 4, 24 and 48
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline for Hematology Parameters: Erythrocytes
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline for Hematology Parameters: Hematocrit
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline for Hematology Parameters: Hemoglobin
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance
Time Frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48
Time Frame: Baseline (Day 1) and at Week 48
Blood samples were collected at Baseline and at Week 48 to assess glucose and fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only fasting data is presented for glucose and lipids. Baseline value is defined as the last available fasting recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at Week 48 visit (if collected while fasting) minus the Baseline value.
Baseline (Day 1) and at Week 48
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 24 and 48
Change From Baseline Values in Urine Creatinine Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 24 and 48
Change From Baseline Values in Urine Phosphate Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 24 and 48
Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Week 48
Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Week 48
Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.
Baseline (Day 1) and at Weeks 4, 24 and 48
Change From Baseline Values in Urine pH Over Time Including Week 48
Time Frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline (Day 1) and at Weeks 4, 24 and 48
Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48
Time Frame: Up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. All Maintenance Phase adverse events (start date occurring on or after the date of first dose of randomized study treatment) leading to withdrawal have been presented.
Up to Week 48
Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48
Time Frame: Baseline (Day 1) and at Week 48
Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the last available recorded fasting value up to and including the date of first Maintenance Phase dose of IP. Percentage change from baseline is calculated as: value at Week 48 (if collected while fasting) minus Baseline value divided by Baseline value multiplied by 100.
Baseline (Day 1) and at Week 48
Number of Participants With Phenotypic Resistance Through Week 48
Time Frame: Week 48
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Phenotypic Resistance data for following drugs :CAB,dolutegravir(DTG),elvitegravir (EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance (FC>clinical higher cutoff/biologic cutoff),partially sensitive (FC=clinical higher cutoff and > clinical lower cutoff),sensitive(FC<=clinical lower cutoff/biologic cutoff). The CVF population comprised of all participants in ITT-E population who met CVF criteria
Week 48
Number of Participants With Genotypic Resistance Through Week 48
Time Frame: Week 48
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.
Week 48
Area Under the Curve (AUC) for CAB LA
Time Frame: Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48
AUC values are Bayesian pharmacokinetic (PK) parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for CAB LA. The PK Population includes all participants who received CAB and / or RPV and undergo PK sampling during the study, and provide CAB and /or RPV plasma concentration data.
Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48
AUC for RPV LA
Time Frame: Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48
AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for RPV LA
Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Time Frame: Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected at indicated time points for PK analysis of CAB LA.
Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Ctrough for RPV LA Evaluable
Time Frame: Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Blood samples were collected at indicated time points for PK analysis of RPV LA.
Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF)
Time Frame: Weeks 5 and at Weeks 41 and 48
PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis
Weeks 5 and at Weeks 41 and 48
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire
Time Frame: Weeks 5, 41 and 48
PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis.
Weeks 5, 41 and 48
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire
Time Frame: Baseline (Day 1) and at Weeks 24 and 48
The HATQoL questionnaire was used to assess health related QoL (HRQoL). It comprises of three dimensions: life satisfaction (LISAT), medication worries (MEDWO) and disclosure worries (DISWO). For LISAT domain, each question is scored as 1-5, where 5 corresponds to satisfaction 'all of time' and 1 as 'none of time'. Total score for the LISAT domain (sum of item scores for questions 1a to 1d) is transformed to a 0-100 scale using formula:[100 divided by (20 minus 4)]*(raw total score for LISAT minus 4). Higher the LISAT score, greater satisfaction to life. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in HIV Medication, MEDWO Using HATQoL
Time Frame: Baseline and at Weeks 24 and 48
The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the MEDWO domain, each question is scored as 1-5, where 5 is associated with medication worry 'none of the time' and 1 as 'all of the time'. The total score for the MEDWO domain (sum of item scores for questions 2a to 3e) is transformed to a 0-100 scale using formula: [100 divided by (25 minus 5)]* (raw total score for MEDWO minus 5). Higher MEDWO scores correspond to lower medication worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Baseline and at Weeks 24 and 48
Change From Baseline in DISWO Using HATQoL
Time Frame: Baseline and at Weeks 24 and 48
The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the DISWO domain, each question is scored as 1-5, where 5 is associated with disclosure worry 'none of the time' and 1 as 'all of the time'. The total score for the DISWO domain (sum of item scores for questions 3a to 3e) is transformed to a 0-100 scale using formula: [100 divided by (25 minus 5)]* (raw total score for DISWO minus 5). Higher DISWO total scores correspond to lower disclosure worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Baseline and at Weeks 24 and 48
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12)
Time Frame: Baseline and at Weeks 24 and 48
The SF-12 questionnaire consists of 7 questions which measures degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. HRQoL using SF-12 for physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing component scores was imputed using LOCF.PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com).The higher the score, the better will be the health status.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Baseline and at Weeks 24 and 48
Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44
Time Frame: Baseline and at Weeks 4b, 24 and 44
HIVTSQs (status version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Adjusted mean and 95% CI of adjusted mean values has been presented.
Baseline and at Weeks 4b, 24 and 44
Change in Treatment Satisfaction Over Time Using HIVTSQc at Week 48
Time Frame: Week 48
HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores representedeterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Week 48
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44
Time Frame: Baseline and at Weeks 4b, 24 and 44
HIVTSQs (status version) is a 12 item questionnaire. The individual item scores are ratedas 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Baseline and at Weeks 4b, 24 and 44
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire
Time Frame: Baseline and at Weeks 8, 24 and 48
ACCEPT questionnaire is generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists 25 items, capturing six dimensions. 3 questions focusing on general acceptance of study medication were analyzed. Items scores are rated as 1-5 :1-totally disagree,2-somewhat disagree,3-somewhat agree,4-totally agree and 5-I don't know. The acceptance domain score (ranging from 0 to 100) is calculated using the following formula:100*(mean of recoded items in dimension minus 1) divided by 2.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Baseline and at Weeks 8, 24 and 48
Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm
Time Frame: Weeks 4b, 5, 40 and 41
The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF.
Weeks 4b, 5, 40 and 41

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Different Demographic Parameters for Inter-subject Variability
Time Frame: Up to Week 48
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 subject variability for pharmacokinetic parameters.
Up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline
Janssen Pharmaceuticals

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2016

Primary Completion (Actual)

August 30, 2018

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimated)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201584
  • 2016-001646-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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