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
NCT ID: NCT02603120
Last Updated: 2020-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
567 participants
INTERVENTIONAL
2015-11-11
2019-10-23
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
DOUBLE
Study Groups
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Blinded Phase: B/F/TAF
B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks
B/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
ABC/DTG/3TC Placebo
Tablets administered orally once daily without regard to food
Blinded Phase: ABC/DTG/3TC
ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
ABC/DTG/3TC
600/50/300 mg FDC tablets administered orally once daily without regard to food
B/F/TAF Placebo
Tablets administered orally once daily without regard to food
Open-Label Phase
At 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.
B/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
Interventions
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ABC/DTG/3TC
600/50/300 mg FDC tablets administered orally once daily without regard to food
B/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
ABC/DTG/3TC Placebo
Tablets administered orally once daily without regard to food
B/F/TAF Placebo
Tablets administered orally once daily without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Phoenix, Arizona, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Oakland, California, United States
Oakland, California, United States
Palm Springs, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Leandro, California, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
Wilton Manors, Florida, United States
Augusta, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Berkley, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
Santa Fe, New Mexico, United States
Buffalo, New York, United States
New York, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Huntersville, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
Seattle, Washington, United States
Spokane, Washington, United States
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Ghent, , Belgium
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Nantes, , France
Nice, , France
Paris, , France
Paris, , France
Berlin, , Germany
Berlin, , Germany
Bonn, , Germany
Essen, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Munich, , Germany
München, , Germany
Roma, , Italy
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Badalona, , Spain
Badalona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Brighton, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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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.
Molina 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.
Brar 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.
Avihingsanon 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.
Wohl 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.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 1
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-004025-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-380-1844
Identifier Type: -
Identifier Source: org_study_id