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

NCT04542070 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 213500
• Study Type: interventional
• Target: 687
• Locations: 13 countries
• Sites: 114

Brief 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.

Conditions

HIV Infections

Keywords

HIV; Cabotegravir; Rilpivirine; BIKTARVY; Antiretroviral therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  At month 12/11

• 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.

  At month 12/11

Secondary Outcomes (31)

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

  At month 12/11

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

  At month 12/11

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

  At month 6/5

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

  At month 6/5

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

  Up to month 12

Study Arms (4)

Biktarvy (BIK)

ACTIVE COMPARATOR

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).

Drug: BIKTARVY Tablets (BIK)

Oral lead-in phase (OLI)

EXPERIMENTAL

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

Drug: Cabotegravir Tablets; Drug: Rilpivirine Tablets

Direct to injections (D2I)

EXPERIMENTAL

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.

Drug: Cabotegravir Injectable Suspension (CAB LA); Drug: Rilpivirine Injectable Suspension (RPV LA)

Switch Q2M Group

ACTIVE COMPARATOR

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.

Drug: Cabotegravir Injectable Suspension (CAB LA); Drug: Rilpivirine Injectable Suspension (RPV LA)

Interventions

Cabotegravir Tablets DRUG

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

Oral lead-in phase (OLI)

Cabotegravir Injectable Suspension (CAB LA) DRUG

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

Direct to injections (D2I); Switch Q2M Group

Rilpivirine Tablets DRUG

RPV was administered as tablets for oral administration.

Oral lead-in phase (OLI)

Rilpivirine Injectable Suspension (RPV LA) DRUG

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

Direct to injections (D2I); Switch Q2M Group

BIKTARVY Tablets (BIK) DRUG

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

Biktarvy (BIK)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Janssen, LP: collaborator

Study Sites (117)

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Beverly Hills, California, 90211, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Los Angeles, California, 90033, United States

Location

GSK Investigational Site

Los Angeles, California, 90036, United States

Location

GSK Investigational Site

Palm Springs, California, 92262, United States

Location

GSK Investigational Site

San Francisco, California, 94102, United States

Location

GSK Investigational Site

Denver, Colorado, 80204, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06510, United States

Location

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

Location

GSK Investigational Site

Miami, Florida, 33133, United States

Location

GSK Investigational Site

Pensacola, Florida, 32503, United States

Location

GSK Investigational Site

Tampa, Florida, 33602, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33407, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30033, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Chicago, Illinois, 60613, United States

Location

GSK Investigational Site

Kansas City, Kansas, 66160, United States

Location

GSK Investigational Site

Wichita, Kansas, 67214, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70112, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70117, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21201, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02043, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02115, United States

Location

GSK Investigational Site

Southfield, Michigan, 48075, United States

Location

GSK Investigational Site

Newark, New Jersey, 07103, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27401-1209, United States

Location

GSK Investigational Site

Greenville, North Carolina, 27834, United States

Location

GSK Investigational Site

Huntersville, North Carolina, 28078, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

Location

GSK Investigational Site

Toledo, Ohio, 43614, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Bellaire, Texas, 77401, United States

Location

GSK Investigational Site

Dallas, Texas, 75208, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Houston, Texas, 77098, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

GSK Investigational Site

Darlinghurst, Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Prahran, Victoria, 3181, Australia

Location

GSK Investigational Site

Innsbruck, A-6020, Austria

Location

GSK Investigational Site

Linz, 4021, Austria

Location

GSK Investigational Site

Vienna, A-1090, Austria

Location

GSK Investigational Site

Hasselt, 3500, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Lodelinsart, 6042, Belgium

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5B 1W8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1K2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4E9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3A 1T1, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

Regina, Saskatchewan, S4P 0W5, Canada

Location

GSK Investigational Site

Bobigny, 93009, France

Location

GSK Investigational Site

Bordeaux, 33076, France

Location

GSK Investigational Site

Clermont-Ferrand, 63000, France

Location

GSK Investigational Site

Créteil, 94010, France

Location

GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Nice, 06202, France

Location

GSK Investigational Site

Tourcoing, 59208, France

Location

GSK Investigational Site

Munich, Bavaria, 80336, Germany

Location

GSK Investigational Site

Aachen, North Rhine-Westphalia, 52062, Germany

Location

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44787, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50668, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50674, Germany

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, 10439, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

Dublin, 8, Ireland

Location

GSK Investigational Site

Dublin, D09 V2N0, Ireland

Location

GSK Investigational Site

Modena, Emilia-Romagna, 41124, Italy

Location

GSK Investigational Site

Rome, Lazio, 00149, Italy

Location

GSK Investigational Site

Bergamo, Lombardy, 24127, Italy

Location

GSK Investigational Site

Brescia, Lombardy, 25123, Italy

Location

GSK Investigational Site

Busto Arsizio (VA), Lombardy, 21052, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20127, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20157, Italy

Location

GSK Investigational Site

Pavia, Lombardy, 27100, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10149, Italy

Location

GSK Investigational Site

Aichi, 460-0001, Japan

Location

GSK Investigational Site

Osaka, 540-0006, Japan

Location

GSK Investigational Site

Tokyo, 108-8639, Japan

Location

GSK Investigational Site

Tokyo, 162-8655, Japan

Location

GSK Investigational Site

Amsterdam, 1091 HA, Netherlands

Location

GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

GSK Investigational Site

Alcalá de Henares, 28805, Spain

Location

GSK Investigational Site

Burgos, 09006, Spain

Location

GSK Investigational Site

Huelva, 21005, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Majadahonda( Madrid, 28222, Spain

Location

GSK Investigational Site

Sant Boi de Llobregat, 08830, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

GSK Investigational Site

Valencia, 46010, Spain

Location

GSK Investigational Site

Valencia, 46015, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

Bern, 3010, Switzerland

Location

GSK Investigational Site

Geneva, CH-1205, Switzerland

Location

GSK Investigational Site

Lausanne, 1011, Switzerland

Location

GSK Investigational Site

Zurich, 8091, Switzerland

Location

GSK Investigational Site

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

GSK Investigational Site

Glasgow, G12 OYN, United Kingdom

Location

GSK Investigational Site

London, SE1 9RT, United Kingdom

Location

GSK Investigational Site

London, SW10 9TH, United Kingdom

Location

GSK Investigational Site

Manchester, M8 5RB, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 36626155 BACKGROUND

• 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.

  PMID: 37567205 BACKGROUND

• 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.

  PMID: 41110828 DERIVED

• 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.

  PMID: 40383512 DERIVED

• 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.

  PMID: 39676239 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir; Rilpivirine; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: ViiV Healthcare

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: November 9, 2020
• Primary Completion: July 13, 2022
• Study Completion: April 17, 2023
• Last Updated: June 4, 2024
• Results First Posted: September 13, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

CH (4); GB (5); FR (8); AU (4); DE (10); US (41); IE (2); NL (2); CA (10); BE (4); ES (11); JP (4); IT (9)