Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed
2 other identifiers
interventional
567
10 countries
94
Brief Summary
The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2015
Typical duration for phase_3
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedStudy Start
First participant enrolled
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2017
CompletedResults Posted
Study results publicly available
July 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2019
CompletedNovember 12, 2020
October 1, 2020
1.5 years
November 10, 2015
May 1, 2018
October 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Week 48
Secondary Outcomes (6)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm
Week 48
Change From Baseline in CD4+ Cell Count at Week 48
Baseline; Week 48
Spine Bone Mineral Density (BMD) at Baseline
Baseline
Percentage Change From Baseline in Spine BMD at Week 48
Baseline; Week 48
Hip Bone Mineral Density at Baseline
Baseline
- +1 more secondary outcomes
Study Arms (3)
Blinded Phase: B/F/TAF
EXPERIMENTALB/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks
Blinded Phase: ABC/DTG/3TC
ACTIVE COMPARATORABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
Open-Label Phase
EXPERIMENTALAt the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.
Interventions
600/50/300 mg FDC tablets administered orally once daily without regard to food
50/200/25 mg FDC tablets administered orally once daily without regard to food
Tablets administered orally once daily without regard to food
Tablets administered orally once daily without regard to food
Eligibility Criteria
You may qualify if:
- Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
- Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
- HIV ribonucleic acid (RNA) \< 50 copies/mL at the screening visit.
- Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
- Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.
You may not qualify if:
- Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
- Active tuberculosis infection.
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- Females who are pregnant.
- Females who are breastfeeding.
- Acute hepatitis in the 30 days prior to study entry.
- Chronic Hepatitis B Virus (HBV) infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (94)
Unknown Facility
Phoenix, Arizona, 85012, United States
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Beverly Hills, California, 90211, United States
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Los Angeles, California, 90027, United States
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Los Angeles, California, 90033, United States
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Los Angeles, California, 90036, United States
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Los Angeles, California, 90069, United States
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Oakland, California, 94602, United States
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Oakland, California, 94609, United States
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Palm Springs, California, 92264, United States
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Sacramento, California, 95187, United States
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Sacramento, California, 95825, United States
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San Leandro, California, 94577, United States
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Washington D.C., District of Columbia, 20009, United States
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Washington D.C., District of Columbia, 20036, United States
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DeLand, Florida, 32720, United States
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Fort Lauderdale, Florida, 33308, United States
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Fort Lauderdale, Florida, 33316, United States
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Ft. Pierce, Florida, 34982, United States
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Miami, Florida, 33133, United States
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Miami Beach, Florida, 33139, United States
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Orlando, Florida, 32803, United States
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Pensacola, Florida, 32504, United States
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Tampa, Florida, 33614, United States
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Vero Beach, Florida, 32960, United States
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West Palm Beach, Florida, 33401, United States
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Wilton Manors, Florida, 33305, United States
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Augusta, Georgia, 30912, United States
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Decatur, Georgia, 30033, United States
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Macon, Georgia, 31201, United States
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Savannah, Georgia, 31401, United States
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Honolulu, Hawaii, 96813, United States
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Chicago, Illinois, 60613, United States
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Chicago, Illinois, 60657, United States
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Louisville, Kentucky, 40202, United States
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New Orleans, Louisiana, 70112, United States
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Boston, Massachusetts, 02118-2393, United States
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Springfield, Massachusetts, 01105, United States
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Berkley, Michigan, 48072, United States
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Detroit, Michigan, 48202, United States
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Minneapolis, Minnesota, 55415, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63139, United States
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Newark, New Jersey, 07102, United States
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Santa Fe, New Mexico, 87505, United States
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Buffalo, New York, 14215, United States
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New York, New York, 10011, United States
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The Bronx, New York, 10467-2490, United States
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Charlotte, North Carolina, 28207, United States
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Greenville, North Carolina, 27834, United States
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Huntersville, North Carolina, 28078, United States
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Cincinnati, Ohio, 45267-0560, United States
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Philadelphia, Pennsylvania, 19107, United States
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Columbia, South Carolina, 29203-6840, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75219, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77098, United States
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Longview, Texas, 75605, United States
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Seattle, Washington, 98104, United States
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Spokane, Washington, 99204, United States
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Sydney, New South Wales, 2010 NSW, Australia
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Sydney, New South Wales, 2010, Australia
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Ghent, 9000, Belgium
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Vancouver, British Columbia, V6Z 2T1, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Montreal, Quebec, H2L 4P9, Canada
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Montreal, Quebec, H3A 1T1, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Nantes, 44093, France
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Nice, 6202, France
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Paris, 75010, France
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Paris, 75970, France
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Berlin, 12157, Germany
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Essen, 45122, Germany
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Frankfurt am Main, 60596, Germany
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Hamburg, 20146, Germany
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Munich, 80336, Germany
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München, 80335, Germany
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Roma, 00149, Italy
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San Juan, 00909-1711, Puerto Rico
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San Juan, 00909, Puerto Rico
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Badalona, 08916, Spain
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Badalona, 8907, Spain
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Barcelona, 8025, Spain
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Córdoba, 14004, Spain
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Madrid, 28034, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41013, Spain
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Brighton, BN2 3EW, United Kingdom
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Manchester, M13 0FH, United Kingdom
Unknown Facility
Manchester, M8 5RB, United Kingdom
Related Publications (5)
Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347.
PMID: 31430369RESULTMolina JM, Ward D, Brar I, Mills A, Stellbrink HJ, Lopez-Cortes L, Ruane P, Podzamczer D, Brinson C, Custodio J, Liu H, Andreatta K, Martin H, Cheng A, Quirk E. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e357-e365. doi: 10.1016/S2352-3018(18)30092-4. Epub 2018 Jun 18.
PMID: 29925489RESULTBrar I, Ruane PJ, Berhe M, Brinson C, Benson P, Henry K, Liu H, Andreatta K, Hindman JT, Ramgopal M. Efficacy and safety of switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir/abacavir/lamivudine: Results from an open-label extension of a phase 3 randomized, double-blind, multicenter, active-controlled, non-inferiority study. Medicine (Baltimore). 2025 Feb 21;104(8):e41482. doi: 10.1097/MD.0000000000041482.
PMID: 39993074DERIVEDAvihingsanon A, Chetchotisakd P, Kiertiburanakul S, Ratanasuwan W, Siripassorn K, Supparatpinyo K, Martin H, Wang H, Wong T, Wang HY. Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials. HIV Med. 2023 Mar;24(3):290-300. doi: 10.1111/hiv.13386. Epub 2022 Aug 17.
PMID: 36912172DERIVEDWohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.
PMID: 29956087DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 11, 2015
Study Start
November 11, 2015
Primary Completion
May 9, 2017
Study Completion
October 23, 2019
Last Updated
November 12, 2020
Results First Posted
July 23, 2018
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.