AzTrials
AzTrials

HIV InfectionsPhase 2NCT03639311

Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

A Phase 2 study testing CAB LA, RPV LA and RPV in people with HIV Infections, run by ViiV Healthcare at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
CAB LA, RPV LA and RPV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
30 sitesin 2 countries
Study dates
24 Sep 2018to 30 Jan 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent.
  • A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test at Day 1), not lactating, and at least with one of following conditions:
  • Non-reproductive potential defined as: (i) Pre-menopausal females with one of the conditions as 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 (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
  • 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 the methods of contraception.
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  • Capable of giving signed informed consent.
  • Must have been on oral CAB 30 mg plus RPV 25 mg regimen through at minimum Week 300 of the LATTE study as per LATTE protocol dosing requirements and until Day 1 of the POLAR study. Any disruptions in dosing during LATTE must be discussed with the Medical Monitor for a final determination of eligibility.
  • Plasma HIV-1 RNA <50 c/mL at Week 300. If participant has plasma HIV-1 RNA >= 50 c/mL at Week 300 in LATTE, a single repeat to determine eligibility may be allowed ONLY after consultation with the medical monitor.

Who cannot join

  • During the last 6 months of participation in LATTE, consecutive (2 or more sequential) plasma HIV-1 RNA measurements >=50 c/mL.
  • During the last 6 months of participation in LATTE, any HIV-1 RNA measurement >=200 c/mL.
  • Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy.
  • Participants with moderate to severe hepatic impairment determined by Child-Pugh classification.
  • 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 enrolment if the Investigator believes the risk of seizure recurrence is low.
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  • 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.
  • Participants 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 for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV 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.
  • 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 within 12 months must be excluded. (HCV treatment on study may be permitted, following consultation with the medical monitor).
  • Participants with HCV co-infection will be allowed entry into this study if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, and is not advanced.
  • 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 inconclusive, the fibrosis- 4 (Fib-4) score will be used to verify eligibility where Fib-4 score >3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation where the Fibrosis 4 Score Formula: age multiplied by aspartate amino transferase (AST) divided by platelets multiplied by square of alanine aminotransferase (ALT).
  • 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 pharmacokinetic (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 (less than or equal to [<=]325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
  • Corrected QT interval (QTc (Bazett)) >450 millisecond (msec) or QTc (Bazett) >480 msec for participants with bundle branch block.
  • Any verified Grade 4 laboratory abnormality over the last 6 months in LATTE. A single repeat test is allowed to verify a result.
  • Any acute laboratory abnormality over the last 6 months in LATTE, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
  • ALT>=5 times upper limit of normal (ULN) or ALT >= 3 times ULN and bilirubin >= 1.5 times ULN (with >35 percent [%] direct bilirubin) over the last 6 months in LATTE.
  • Exposure to an experimental drug (with the exception of those in the LATTE study including CAB and RPV) 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 Day 1: radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]); anti-coagulation agents.
  • Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
  • Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility.
  • Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States25 sites

  • GSK Investigational Site

    Annandale, Virginia, 22003

  • GSK Investigational Site

    Augusta, Georgia, 30912-3130

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Bakersfield, California, 93301

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Denver, Colorado, 80209

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Los Angeles, California, 90069

  • GSK Investigational Site

    Macon, Georgia, 31201

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    New York, New York, 10065

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Phoenix, Arizona, 85015

  • GSK Investigational Site

    Savannah, Georgia, 31401

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

Other trials in United States

Canada5 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 4E9

  • GSK Investigational Site

    Montreal, Quebec, H3A 1T1

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Toronto, Ontario, M5G 1K2

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2T1

Other trials in Canada

About this study

Official title: A Phase IIb, Multicenter, Open-label, Rollover Study Evaluating the Efficacy, Safety and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months in HIV-1 Infected Adults Who Are Virologically Suppressed and Participated in Study LAI116482

This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants. Participants will rollover from the NCT01641809 (LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (less than [<]50 copies (c) per milliliter [mL]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The participants will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval). Duration of study will vary from country to country, until regimen receives regulatory approval and becomes commercially available. The study plans to enroll approximately 100 participants. Any participant who receives at least one dose of CAB LA and/or RPV LA and discontinues the CAB LA plus RPV LA regimen for any reason will enter a 52-week Long-Term Follow-Up (LTFU) phase. Those participants must remain on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and or RPV LA.

Conditions
HIV Infections
Being tested
CAB LA, RPV LA, RPV, DTG
Keywords
HIV, Antiretroviral therapy, Maintenance, Long acting, LATTE
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAB LADrug

    Administered CAB LA (600 mg) Q2M, as intramuscular injection.

  • RPV LADrug

    Administered RPV LA (900 mg), Q2M, as intramuscular injection.

  • RPVDrug

    Oral dose of RPV 25 mg, administered once daily from Day 1 up to Month 12

  • DTGDrug

    Oral dose of DTG 50 mg administered once daily from Day 1 up to Month 12.

Study groups in NCT03639311
Study groupRoleWhat they receive
CAB LA + RPV LA Q2MExperimentalEligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.
Receives: Drug: CAB LA; Drug: RPV LA
DTG + RPVExperimentalEligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Receives: Drug: RPV; Drug: DTG
LTFU: CAB LA+RPV LA Q2M GroupExperimentalThis group included the participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason before end of Maintenance Period. The participants entered a 52-week LTFU period.
Receives: Drug: CAB LA; Drug: RPV LA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase]

    Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (ART) experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.

    Measured: At Month 12 [Maintenance Phase]

Secondary outcomes (61)

  1. Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 [Maintenance Phase]

    Percentage of participants with HIV-1 RNA <50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA <50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.

    Measured: At Month 12 [Maintenance Phase]

  2. Number of Participants With Protocol-defined Confirmed Virologic Failure up to End of Maintenance Phase

    Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 c/mL after prior suppression to <200 c/mL.

    Measured: Up to End of Maintenance Phase (up to Month 52 for CAB LA+RPV LA Q2M group, up to Month 12 for DTG+RPV group)

  3. Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase]

    Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: At Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12 [Maintenance Phase]

  4. Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase]

    Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]

  5. Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Standard Deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

    Measured: From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

  6. Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

    Measured: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]

  7. Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  8. Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  9. Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

  10. Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]

  11. Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  12. Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  13. Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for CAB LA + RPV LA Q2M Arm

    An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.

    Measured: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

  14. Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for DTG + RPV Arm

    An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.

    Measured: Up to Month 12 [Maintenance Phase]

  15. Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm

    Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).

    Measured: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

  16. Number of Participants With Severity of Adverse Events for DTG + RPV Arm

    Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).

    Measured: Up to Month 12 [Maintenance Phase]

  17. Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase

    Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).

    Measured: Up to End of Maintenance Phase (up to Month 52)

  18. Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).

    Measured: Up to Month 12 [Maintenance Phase]

  19. Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase

    The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).

    Measured: Up to End of Maintenance Phase (up to Month 52)

  20. Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).

    Measured: Up to Month 12 [Maintenance Phase]

  21. Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase

    An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants with adverse events leading to permanent withdrawal has been presented.

    Measured: Up to End of Maintenance Phase (up to Month 52)

  22. Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants with adverse events leading to permanent withdrawal has been presented.

    Measured: Up to Month 12 [Maintenance Phase]

  23. Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  24. Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  25. Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase

    Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  26. Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  27. Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  28. Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  29. Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. SD=0.00(0) is defined as SD resulted below the detectable limit of the assay and approximate to 0.00(0).

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  30. Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  31. Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, direct high density lipoprotein cholesterol, LDL cholesterol calculation, direct low density lipoprotein cholesterol and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  32. Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline

    Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides.

    Measured: At Baseline (Day 1)

  33. Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  34. Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  35. Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  36. Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  37. Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of clinical chemistry parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  38. Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of clinical chemistry parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  39. Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  40. Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm at Month 6 [Maintenance Phase]

    Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Month 6 (compared with Baseline [Day 1]) [Maintenance Phase]

  41. Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  42. Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  43. Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  44. Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  45. Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  46. Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  47. Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  48. Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  49. Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

    Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

  50. Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase]

    Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  51. Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio

    Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.

    Measured: At Baseline (Day 1)

  52. Absolute Values of Urine Creatinine

    Urine samples were collected for the analysis of urine creatinine.

    Measured: At Baseline (Day 1)

  53. Absolute Values of Urine Phosphate

    Urine samples were collected for the analysis of urine phosphate.

    Measured: At Baseline (Day 1)

  54. Absolute Values of Urine Specific Gravity

    Urine 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.

    Measured: At Baseline (Day 1)

  55. Absolute Values of Urine Potential of Hydrogen (pH)

    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).

    Measured: At Baseline (Day 1)

  56. Number of Participants With Treatment Emergent Genotypic Resistance

    Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria.

    Measured: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

  57. Number of Participants With Treatment Emergent Phenotypic Resistance

    Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.

    Measured: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

  58. Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV)

    HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted Impact Score (WIS) was calculated for the 26 domain items by multiplying impact score(IS) (-3[maximum {max.} negative impact] to +1[max. positive impact] by the corresponding importance score (3 [very important] to 0[not all important]). Average Weighted Impact (AWI) score was calculated by summing individual weighted IS and dividing by the number of domain items. The ranges of WIS and average IS were from -9(max. negative) to +3(max. positive);higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value). SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.

    Measured: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  59. Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)

    HIVTSQs 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 as compared to the past few weeks; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.

    Measured: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  60. Change From Baseline in Individual Item Score of HIVTSQs

    HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 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. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.

    Measured: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

  61. Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)

    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 represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score was not computed and remained missing.

    Measured: At Month 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2018
  2. Study start24 Sep 2018
  3. Primary completion11 Dec 2019
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This is an Intervention Model, with parallel assignment, where the primary purpose of the study is, treatment, with 2 arms and no masking.
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03639311
Sponsor's protocol ID
209035
Status last verified
May 2024
First submitted
10 Aug 2018
Last updated
11 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Okesanya OJ, Ayeni RA, Amadin P, Ngwoke I, Amisu BO, Ukoaka BM, Ahmed MM, Oso TA, Musa SS, Lucero-Prisno DE. Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control. AIDS Res Treat. 2025 Jul 4;2025:6829446. doi: 10.1155/arat/6829446. eCollection 2025.

    PubMed 40655875

  • Mills A, Richmond GJ, Newman C, Osiyemi O, Cade J, Brinson C, De Vente J, Margolis DA, Sutton KC, Wilches V, Hatch S, Roberts J, McCoig C, Garris C, Vandermeulen K, Spreen WR. Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. AIDS. 2022 Feb 1;36(2):195-203. doi: 10.1097/QAD.0000000000003085.

    PubMed 34652287

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CAB LA, RPV LA and RPV in people with HIV Infections, run by ViiV Healthcare at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase] (time frame: At Month 12 [Maintenance Phase]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03639311, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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