AzTrials
AzTrials

HIV InfectionsPhase 3SOLARNCT04542070

A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

A Phase 3 study testing Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA) and Rilpivirine Tablets in people with HIV Infections, run by ViiV Healthcare at 117 sites in 14 countries.

Completed

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

Official record
Search all trials

Trial summary

This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences. 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?
Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA) and Rilpivirine Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
687 participants
Where
117 sitesin 14 countries
Study dates
9 Nov 2020to 17 Apr 2023
Phase
Phase 3
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

  • Participants 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 serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), 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.
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  • 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 enrollment.
  • Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
  • Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
  • Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. BIK must be the participant's first or second regimen. If BIK is the second regimen, the first regimen must be an integrase inhibitor (INI) regimen. Only a single prior Integrase inhibitor (INI) regimen is allowed if BIK is a second line regimen >=6 months prior to screening. Any history of non-integrase strand transfer inhibitor regimens (that is. non-nucleoside reverse transcriptase inhibitor, protease inhibitor, C-C chemokine receptor 5 and other entry inhibitors) are not permitted. Any prior change in regimen, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for treatment failure (HIV-1 RNA >=400 c/mL).
  • The following are limited exceptions:
  • A change from Tenofovir disoproxil fumarate (TDF) to TAF will not be considered a regimen change.
  • Historical perinatal use of Nucleoside reverse transcriptase inhibitor (NRTI) when given in addition to an ongoing Highly active antiretroviral therapy (HAART) will not be considered a change in ART therapy regimen.
  • The past use of ARVs in the context of Post Exposure Prophylaxis (PEP) or Pre-Exposure Prophylaxis (PrEP) while the participant was HIV negative will be allowed. Such cases will be evaluated on a case by case basis with the Medical Monitor, and may require documentation of HIV negative serology during time of PEP or PrEP.
  • A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy.
  • A change in formulation from multiple class regimens to single treatment regimens (of the same medications) would not be considered a change in ART regimen.
  • Documented evidence of plasma HIV-1 RNA measurements <50 c/mL in the 6 months prior to Screening.
  • Plasma HIV-1 RNA <50 c/mL at Screening.

Who cannot join

  • Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >=50 c/mL.
  • Within the 6 to 12-month window prior to Screening, documented evidence of any plasma HIV-1 RNA measurement greater than (>)200 c/mL, or 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
  • History of prior treatment failure to any Department of Health and Human Services (DHHS) recommended ART regimen.
  • History of drug holiday >1 month for any reason prior to Screening visit, except where all ART was stopped due to tolerability and/or safety concerns.
  • Any change to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement >=200 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen).
  • Participants who are currently participating in or anticipate being selected for any other interventional study.
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  • Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
  • Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts <200 cells/microliter are not exclusionary.
  • Participants with moderate to severe hepatic impairment.
  • Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
  • Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment.
  • All participants will be screened for syphilis.
  • Participants with untreated secondary (late latent) or tertiary syphilis infection, defined as a positive rapid plasma reagin (RPR) and a positive treponemal test without clear documentation of treatment, are excluded.
  • Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor.
  • Participants with primary syphilis or early latent secondary syphilis (acquired within the preceding year) who have a positive RPR test and have not been treated may be treated during the screening period and if completion of antibiotic treatment occurs during the screening period, may be allowed entry after consultation with the Medical Monitor. If antibiotic treatment cannot be completed before the screening window ends, participants may be rescreened once following completion of antibiotic therapy for primary or early latent secondary syphilis.
  • 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.
  • The participant has a tattoo, gluteal implant/enhancements 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 deoxyribonucleic acid (DNA) as follows:
  • Participants positive for HBsAg are excluded.
  • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or 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 require or qualify for immediate HCV treatment are excluded for those co-infected participants who post entry into Switch Onto Long Acting Regimen (SOLAR) decide treatment for HCV infection is warranted or desired either by the participant or by the treating physician.
  • 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, and will not require treatment prior to the Month 14 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 inconclusive, the fibrosis (Fib)-4 score will be used to verify eligibility
  • Fib-4 score >3.25 is exclusionary ii. Fib-4 scores 1.45-3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: d. Age x aspartate aminotransferase (AST)/ Platelets x (square [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, or decompensated cirrhosis [for example {e.g.} ascites, encephalopathy, or variceal bleeding]), 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 milligram) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
  • Corrected QT interval (QTc [Bazett]) >450 milliseconds (msec) or QTc (Bazett) >480 msec for participants with bundle branch block.
  • Known or suspected active Coronavirus Disease-2019 (COVID-19) infection or has had contact with an individual with known COVID-19, within 14 days of study enrollment.
  • Known or suspected presence of resistance mutations as defined by the International Antiviral Society-United States of America (IAS-USA) resistance guidelines to the individual components of BIK (BIC, FTC, TAF), RPV, and CAB by any historical resistance test result.
  • Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
  • Participant has estimated creatine clearance <30mL/minute per 1.73 meter square (m^2) via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method.
  • ALT >=3 times upper limit of normal (ULN).
  • Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study.
  • Treatment with any of the following agents within 28 days of Screening:
  • 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.
  • 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 study Day 1. Treatment with acyclovir/valacyclovir is permitted.
  • Use of medications which are associated with Torsade de Pointes.
  • Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.

Trial locations and contacts

117 sites in 14 countries.

117 sites in 14 countries

United States41 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30033

  • GSK Investigational Site

    Bakersfield, California, 93301

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Bellaire, Texas, 77401

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Boston, Massachusetts, 02043

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Chicago, Illinois, 60613

  • GSK Investigational Site

    Dallas, Texas, 75208

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Denver, Colorado, 80204

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982

  • GSK Investigational Site

    Greensboro, North Carolina, 27401-1209

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Houston, Texas, 77098

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Los Angeles, California, 90036

  • GSK Investigational Site

    Miami, Florida, 33133

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    New Orleans, Louisiana, 70112

  • GSK Investigational Site

    New Orleans, Louisiana, 70117

  • GSK Investigational Site

    Newark, New Jersey, 07103

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    San Francisco, California, 94102

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Southfield, Michigan, 48075

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Tampa, Florida, 33602

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    Toledo, Ohio, 43614

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Wichita, Kansas, 67214

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

Other trials in United States

Spain11 sites

  • GSK Investigational Site

    Alcalá de Henares, 28805

  • GSK Investigational Site

    Burgos, 09006

  • GSK Investigational Site

    Huelva, 21005

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Majadahonda( Madrid, 28222

  • GSK Investigational Site

    Sant Boi de Llobregat, 08830

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Valencia, 46015

  • GSK Investigational Site

    Valencia, 46026

Other trials in Spain

Canada10 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 4E9

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9

  • GSK Investigational Site

    Montreal, Quebec, H3A 1T1

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Regina, Saskatchewan, S4P 0W5

  • GSK Investigational Site

    Toronto, Ontario, M5B 1W8

  • GSK Investigational Site

    Toronto, Ontario, M5G 1K2

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Germany10 sites

  • GSK Investigational Site

    Aachen, North Rhine-Westphalia, 52062

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10439

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44787

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50668

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50674

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Munich, Bavaria, 80336

Other trials in Germany

Italy9 sites

  • GSK Investigational Site

    Bergamo, Lombardy, 24127

  • GSK Investigational Site

    Brescia, Lombardy, 25123

  • GSK Investigational Site

    Busto Arsizio (VA), Lombardy, 21052

  • GSK Investigational Site

    Milan, Lombardy, 20127

  • GSK Investigational Site

    Milan, Lombardy, 20157

  • GSK Investigational Site

    Modena, Emilia-Romagna, 41124

  • GSK Investigational Site

    Pavia, Lombardy, 27100

  • GSK Investigational Site

    Rome, Lazio, 00149

  • GSK Investigational Site

    Turin, Piedmont, 10149

Other trials in Italy

France8 sites

  • GSK Investigational Site

    Bobigny, 93009

  • GSK Investigational Site

    Bordeaux, 33076

  • GSK Investigational Site

    Clermont-Ferrand, 63000

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Le Kremlin-Bicêtre, 94275

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Nice, 06202

  • GSK Investigational Site

    Tourcoing, 59208

Other trials in France

United Kingdom5 sites

  • GSK Investigational Site

    Glasgow, G12 OYN

  • GSK Investigational Site

    Liverpool, Merseyside, L7 8XP

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    London, SW10 9TH

  • GSK Investigational Site

    Manchester, M8 5RB

Other trials in United Kingdom

Australia4 sites

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010

  • GSK Investigational Site

    Darlinghurst, Sydney, New South Wales, 2010

  • GSK Investigational Site

    Prahran, Victoria, 3181

  • GSK Investigational Site

    Sydney, New South Wales, 2010

Other trials in Australia

Belgium4 sites

  • GSK Investigational Site

    Hasselt, 3500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Lodelinsart, 6042

Other trials in Belgium

Japan4 sites

  • GSK Investigational Site

    Aichi, 460-0001

  • GSK Investigational Site

    Osaka, 540-0006

  • GSK Investigational Site

    Tokyo, 108-8639

  • GSK Investigational Site

    Tokyo, 162-8655

Other trials in Japan

Switzerland4 sites

  • GSK Investigational Site

    Bern, 3010

  • GSK Investigational Site

    Geneva, CH-1205

  • GSK Investigational Site

    Lausanne, 1011

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

Austria3 sites

  • GSK Investigational Site

    Innsbruck, A-6020

  • GSK Investigational Site

    Linz, 4021

  • GSK Investigational Site

    Vienna, A-1090

Other trials in Austria

Ireland2 sites

  • GSK Investigational Site

    Dublin, 8

  • GSK Investigational Site

    Dublin, D09 V2N0

Other trials in Ireland

Netherlands2 sites

  • GSK Investigational Site

    Amsterdam, 1091 HA

  • GSK Investigational Site

    Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Official title: A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed

This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

Conditions
HIV Infections
Being tested
Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), Rilpivirine Tablets, Rilpivirine Injectable Suspension (RPV LA), BIKTARVY Tablets (BIK)
Keywords
HIV, Cabotegravir, Rilpivirine, BIKTARVY, Antiretroviral therapy
Medical subject headings
HIV Infections

What participants receive

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

  • Cabotegravir TabletsDrug

    CAB tablets were available as film coated tablets for oral administration.

  • Cabotegravir Injectable Suspension (CAB LA)Drug

    CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.

  • Rilpivirine TabletsDrug

    RPV was administered as tablets for oral administration.

  • Rilpivirine Injectable Suspension (RPV LA)Drug

    RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.

  • BIKTARVY Tablets (BIK)Drug

    BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.

Study groups in NCT04542070
Study groupRoleWhat they receive
Biktarvy (BIK)Active comparatorParticipants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Receives: Drug: BIKTARVY Tablets (BIK)
Oral lead-in phase (OLI)ExperimentalParticipants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase
Receives: Drug: Cabotegravir Tablets; Drug: Rilpivirine Tablets
Direct to injections (D2I)ExperimentalParticipants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.
Receives: Drug: Cabotegravir Injectable Suspension (CAB LA); Drug: Rilpivirine Injectable Suspension (RPV LA)
Switch Q2M GroupActive comparatorEligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.
Receives: Drug: Cabotegravir Injectable Suspension (CAB LA); Drug: Rilpivirine Injectable Suspension (RPV LA)

What is being measured

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

  1. Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population

    Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: At month 12/11

  2. Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population

    Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: At month 12/11

Secondary outcomes (31)

  1. Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population

    Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: At month 12/11

  2. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population

    Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: At month 12/11

  3. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population

    Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: At month 6/5

  4. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population

    Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: At month 6/5

  5. Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11

    Protocol-defined confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >= 200 c/mL (Day 1 values are not applicable) after prior suppression to <200 c/mL. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at Month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Cumulative number of participants with protocol defined CVF through Month 6/5 and 12/11 has been presented.

    Measured: Up to month 12

  6. Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5

    Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 6 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: At month 6/5

  7. Absolute Values of HIV Viral Load

    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. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  8. Change From Baseline in HIV Viral Load

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  9. Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count

    Blood samples were collected and CD4+ cell count was assessed using flow cytometry. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  10. Change From Baseline in CD4+ Cell Count

    Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  11. Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11

    Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.

    Measured: Up to Month 12/11

  12. Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5

    Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.

    Measured: Up to Month 6/5

  13. Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11

    Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.

    Measured: Up to Month 12/11

  14. Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5

    Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.

    Measured: Up to Month 6/5

  15. Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L))

    Serum samples were collected to evaluate bone specific biomarkers: specific alkaline phosphatase, procollagen type 1 N-propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  16. Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L))

    Serum samples were collected to evaluate bone specific biomarkers: serum 25-hydroxyvitamin D. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  17. Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L])

    Serum samples were collected to evaluate renal specific biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  18. Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L))

    Serum samples were collected to evaluate renal specific biomarkers: urine phosphate. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  19. Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L))

    Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein 4. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  20. Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol))

    Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein/creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  21. Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol))

    Serum samples were collected to evaluate renal specific biomarkers: urine beta-2 microglobulin/ creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  22. Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11

    Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and at Month 12/11

  23. Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5

    Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit.

    Measured: Baseline (Day 1) and at month 6/5

  24. Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR)

    The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. HOMA-IR is calculated as fasting insulin microunits per liter (microU/L) multiplied by fasting glucose (nmol/L) divided by 22.5. Higher HOMA-IR values indicate increased insulin resistance; values <2 is generally regarded as normal. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  25. Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M

    Participants who had switched from the daily oral BIK regimen to CAB + RPV, were assessed as per the preference questionnaire every two months. There were 3 preference questions included to assess the preferred treatment 1) Long-acting injectable HIV medication, 2) Daily oral HIV medication, 3) No Preference. This endpoint was only planned to be analyzed for Q2M arm only. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Data represented included maintenance withdrawal or Month 12/11.

    Measured: Up to month 12/11

  26. Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)

    The HIVTSQs total treatment satisfaction score comprised of 11 items based on HIVTSQ questionnaire each graded on a scale of 0 (very dissatisfied) to 6 (very satisfied) which were summed to produce a total score range of 0-66. Higher scores represent greater treatment satisfaction. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  27. Change From Baseline in Individual Item Scores Using HIVTSQs

    The individual item scores on HIVTSQs scale were rated on a scale of 6 (very satisfied, convenient, flexible, etc.) to -6 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: Baseline (Day 1) and up to Month 12

  28. HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11

    HIV treatment satisfaction change questionnaire (HIVTSQc) total Score is computed with items 1-11 which were summed to produce a total score range of -33 to 33. Higher score indicated greater improvement in the satisfaction with the treatment and lower score indicated greater deterioration in treatment satisfaction. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: At Month 12/11

  29. Individual Item Scores of HIVTSQc at Month 12/11

    Individual item scores were rated on a scale of +3 (much more satisfied', 'much more convenient', 'much more flexible') to -3 (much less satisfied', 'much less convenient', 'much less flexible'). Higher score indicates greater improvement, and lower score indicates greater deterioration in satisfaction with each aspect of treatment. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: At Month 12/11

  30. Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M

    The PIN questionnaire was used to explore the dimension scores based on 4 dimensions including acceptance of injection site reactions (ISRs), Bother from ISRs, Leg movement and Sleep categories. Domain scores were calculated as a mean of all items with the domain. The PIN response options range from 1 (totally acceptable) to 5 (not at all acceptable). This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: From Month 2/1 up to Month 12

  31. Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M

    The PIN questionnaire was used to explore the individual item scores based on anxiety before, pain, satisfaction, anxiety after and willingness categories. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is very dissatisfied and 5 was very satisfied. This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

    Measured: From Month 2/1 up to Month 12

Timeline

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

  1. First posted9 Sep 2020
  2. Study start9 Nov 2020
  3. Primary completion13 Jul 2022
  4. Study completion17 Apr 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542070
Sponsor's protocol ID
213500
Acronym
SOLAR
Status last verified
Jun 2024
First submitted
1 Sep 2020
Last updated
4 Jun 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/
Expanded access
Available

Publications

  • Karver TS, Pascual-Bernaldez M, Berni A, Hnoosh A, Castagna A, Messiaen P, Puerto MJG, Bloch M, Adachi E, Sinclair G, Felizarta F, Angel JB, Sutton K, Sutherland-Phillips D, D'Amico R, Kerrigan D. Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial. AIDS Patient Care STDS. 2023 Jan;37(1):53-59. doi: 10.1089/apc.2022.0168.

    PubMed 36626155

  • Ramgopal MN, Castagna A, Cazanave C, Diaz-Brito V, Dretler R, Oka S, Osiyemi O, Walmsley S, Sims J, Di Perri G, Sutton K, Sutherland-Phillips D, Berni A, Latham CL, Zhang F, D'Amico R, Pascual Bernaldez M, Van Solingen-Ristea R, Van Eygen V, Patel P, Chounta V, Spreen WR, Garges HP, Smith K, van Wyk J. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023 Sep;10(9):e566-e577. doi: 10.1016/S2352-3018(23)00136-4. Epub 2023 Aug 8.

    PubMed 37567205

  • Adachi E, Yokomaku Y, Watanabe D, Gatanaga H, Oka S, Shirasaka T, D'Amico R, Sutton K, Sutherland-Phillips D, Roberts J, Thornhill J, Murungi A, Brown K. Month 12 outcomes of switching to long-acting cabotegravir + rilpivirine with an oral lead-in versus continuing bictegravir/emtricitabine/tenofovir alafenamide in the Phase 3b randomized SOLAR study. J Infect Chemother. 2025 Dec;31(12):102834. doi: 10.1016/j.jiac.2025.102834. Epub 2025 Oct 17.

    PubMed 41110828

  • Adachi E, Yokomaku Y, Watanabe D, Gatanaga H, Oka S, Shirasaka T, Wakatabe R, Chamay N, Sutton K, Sutherland-Phillips D, Urbaityte R, D'Amico R, van Wyk J. Efficacy and safety of switching to long-acting cabotegravir + rilpivirine versus continuing bictegravir/emtricitabine/tenofovir alafenamide in Japanese participants: 12-month results from the phase 3b randomized SOLAR trial. J Infect Chemother. 2025 Jul;31(7):102734. doi: 10.1016/j.jiac.2025.102734. Epub 2025 May 16.

    PubMed 40383512

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA) and Rilpivirine Tablets in people with HIV Infections, run by ViiV Healthcare at 117 sites in 14 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 21 inclusion and 52 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 4 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 117 sites in United States, Spain, Canada, Germany, Italy and 9 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 Sep 2023). 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 Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population (time frame: At month 12/11). The study lists 2 primary outcomes in all. 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 NCT04542070, which also lists 5 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 4 Jun 2024.

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