Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
NCT ID: NCT02652624
Last Updated: 2020-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
472 participants
INTERVENTIONAL
2016-02-19
2018-11-26
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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B/F/TAF
Participants will switch to B/F/TAF FDC and receive treatment for 48 weeks.
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
Baseline Regimen
Participants will remain on their baseline regimen of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF for 48 weeks.
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily with food
E/C/F/TDF
150/150/200/300 mg FDC administered orally once daily with food
ATV
ATV 300 mg capsules administered orally once daily with food
RTV
RTV 100 mg tablets administered orally once daily with food
FTC/TDF
200/300 mg tablet administered orally once daily with food
Extension Phase
Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 48 additional weeks.
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
Interventions
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E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily with food
E/C/F/TDF
150/150/200/300 mg FDC administered orally once daily with food
ATV
ATV 300 mg capsules administered orally once daily with food
RTV
RTV 100 mg tablets administered orally once daily with food
FTC/TDF
200/300 mg tablet administered orally once daily with food
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104 or GS-US-292-0111.
* Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit
* Documented plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 12 weeks preceding the Screening visit. After reaching HIV-1 RNA \< 50 copies/mL, single values of HIV-1 RNA
≥ 50 copies/mL followed by re-suppression to \< 50 copies/mL is allowed
* HIV-1 RNA \<50 copies/mL at screening
* Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula at the Screening visit
18 Years
FEMALE
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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Stamford, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Savannah, Georgia, United States
Springfield, Massachusetts, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
Great Neck, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Huntersville, North Carolina, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
Santo Domingo, , Dominican Republic
Santo Domingo, , Dominican Republic
San Juan, , Puerto Rico
Barnaul, , Russia
Irkutsk, , Russia
Khabarovsk, , Russia
Koltsovo, , Russia
Krasnodar, , Russia
Krasnoyarsk, , Russia
Lipetsk, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint-Petersberg, , Russia
Volgograd, , Russia
Voronezh, , Russia
Yekaterinburg, , Russia
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Nonthaburi, , Thailand
Kampala, , Uganda
Countries
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References
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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.
Kityo C, Hagins D, Koenig E, Avihingsanon A, Chetchotisakd P, Supparatpinyo K, Gankina N, Pokrovsky V, Voronin E, Stephens JL, DeJesus E, Wang H, Acosta RK, Cao H, Quirk E, Martin H, Makadzange T. Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019 Nov 1;82(3):321-328. doi: 10.1097/QAI.0000000000002137.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan: Week 48 Statistical Analysis Plan
Document Type: Statistical Analysis Plan: Final Statistical Analysis Plan
Other Identifiers
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GS-US-380-1961
Identifier Type: -
Identifier Source: org_study_id
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