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
NCT ID: NCT04542070
Last Updated: 2024-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
687 participants
INTERVENTIONAL
2020-11-09
2023-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biktarvy (BIK)
Participants 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).
BIKTARVY Tablets (BIK)
BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.
Oral lead-in phase (OLI)
Participants 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
Cabotegravir Tablets
CAB tablets were available as film coated tablets for oral administration.
Rilpivirine Tablets
RPV was administered as tablets for oral administration.
Direct to injections (D2I)
Participants 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.
Cabotegravir Injectable Suspension (CAB LA)
CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.
Rilpivirine Injectable Suspension (RPV LA)
RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.
Switch Q2M Group
Eligible 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.
Cabotegravir Injectable Suspension (CAB LA)
CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.
Rilpivirine Injectable Suspension (RPV LA)
RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.
Interventions
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Cabotegravir Tablets
CAB tablets were available as film coated tablets for oral administration.
Cabotegravir Injectable Suspension (CAB LA)
CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.
Rilpivirine Tablets
RPV was administered as tablets for oral administration.
Rilpivirine Injectable Suspension (RPV LA)
RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.
BIKTARVY Tablets (BIK)
BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.
Eligibility Criteria
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Inclusion Criteria
* 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.
1. Non-reproductive potential defined as:
* Pre-menopausal females with one of the following:
1. Documented tubal ligation.
2. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion.
3. Hysterectomy.
4. Documented Bilateral Oophorectomy
* Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA.
* 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.
Exclusion Criteria
* 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.
* 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:
1. Participants positive for HBsAg are excluded.
2. 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:
1. Liver enzymes meet entry criteria
2. 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.
3. 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
i. 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.
18 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Palm Springs, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
GSK Investigational Site
New Haven, Connecticut, United States
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Ft. Pierce, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Pensacola, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Kansas City, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Baltimore, Maryland, United States
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Boston, Massachusetts, United States
GSK Investigational Site
Boston, Massachusetts, United States
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Southfield, Michigan, United States
GSK Investigational Site
Newark, New Jersey, United States
GSK Investigational Site
Syracuse, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
GSK Investigational Site
Greensboro, North Carolina, United States
GSK Investigational Site
Greenville, North Carolina, United States
GSK Investigational Site
Huntersville, North Carolina, United States
GSK Investigational Site
Wilmington, North Carolina, United States
GSK Investigational Site
Toledo, Ohio, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
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Bellaire, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
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Dallas, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
GSK Investigational Site
Darlinghurst, New South Wales, Australia
GSK Investigational Site
Darlinghurst, Sydney, New South Wales, Australia
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Sydney, New South Wales, Australia
GSK Investigational Site
Prahran, Victoria, Australia
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Innsbruck, , Austria
GSK Investigational Site
Linz, , Austria
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Vienna, , Austria
GSK Investigational Site
Hasselt, , Belgium
GSK Investigational Site
Leuven, , Belgium
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Lodelinsart, , Belgium
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
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Montreal, Quebec, Canada
GSK Investigational Site
Regina, Saskatchewan, Canada
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Bobigny, , France
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Bordeaux, , France
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Clermont-Ferrand, , France
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Créteil, , France
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Le Kremlin-Bicêtre, , France
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Nantes, , France
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Nice, , France
GSK Investigational Site
Tourcoing, , France
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, Germany
GSK Investigational Site
Bonn, North Rhine-Westphalia, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Dublin, , Ireland
GSK Investigational Site
Dublin, , Ireland
GSK Investigational Site
Modena, Emilia-Romagna, Italy
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Bergamo, Lombardy, Italy
GSK Investigational Site
Brescia, Lombardy, Italy
GSK Investigational Site
Busto Arsizio (VA), Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
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Milan, Lombardy, Italy
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Pavia, Lombardy, Italy
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Turin, Piedmont, Italy
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Aichi, , Japan
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Osaka, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Amsterdam, , Netherlands
GSK Investigational Site
Amsterdam, , Netherlands
GSK Investigational Site
Alcalá de Henares, , Spain
GSK Investigational Site
Burgos, , Spain
GSK Investigational Site
Huelva, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Majadahonda( Madrid, , Spain
GSK Investigational Site
Sant Boi de Llobregat, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Bern, , Switzerland
GSK Investigational Site
Geneva, , Switzerland
GSK Investigational Site
Lausanne, , Switzerland
GSK Investigational Site
Zurich, , Switzerland
GSK Investigational Site
Liverpool, Merseyside, United Kingdom
GSK Investigational Site
Glasgow, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
Countries
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References
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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.
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.
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 Oct 17:102834. doi: 10.1016/j.jiac.2025.102834. Online ahead of print.
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.
Tan DHS, Antinori A, Eu B, Galindo Puerto MJ, Kinder C, Sweet D, Van Dam CN, Sutton K, Sutherland-Phillips D, Berni A, Zhang F, Urbaityte R, Baugh B, Spreen W, van Wyk J, Garges HP, Patel P, Batterham R, D'Amico R. Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide. J Acquir Immune Defic Syndr. 2025 Apr 1;98(4):401-409. doi: 10.1097/QAI.0000000000003584. Epub 2025 Feb 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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213500
Identifier Type: -
Identifier Source: org_study_id
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