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
A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF) or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumarate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women
1 other identifier
interventional
472
6 countries
56
Brief Summary
The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2016
Typical duration for phase_3
56 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
January 8, 2016
CompletedFirst Posted
Study publicly available on registry
January 12, 2016
CompletedStudy Start
First participant enrolled
February 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2017
CompletedResults Posted
Study results publicly available
November 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2018
CompletedMarch 4, 2020
November 1, 2019
1.6 years
January 8, 2016
October 2, 2018
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
The percentage of participants with 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 (2)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
Week 48
Change From Baseline in CD4+ Cell Count at Week 48
Baseline; Week 48
Study Arms (3)
B/F/TAF
EXPERIMENTALParticipants will switch to B/F/TAF FDC and receive treatment for 48 weeks.
Baseline Regimen
ACTIVE COMPARATORParticipants will remain on their baseline regimen of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF for 48 weeks.
Extension Phase
EXPERIMENTALFollowing 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.
Interventions
150/150/200/10 mg FDC tablet administered orally once daily with food
150/150/200/300 mg FDC administered orally once daily with food
ATV 300 mg capsules administered orally once daily with food
RTV 100 mg tablets administered orally once daily with food
200/300 mg tablet administered orally once daily with food
50/200/25 mg FDC tablet administered orally once daily without regard to food
Eligibility Criteria
You may qualify if:
- Medically stable HIV-1 infected women who meet the following 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (56)
Unknown Facility
Stamford, Connecticut, 6902, United States
Unknown Facility
Washington D.C., District of Columbia, 20009, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Fort Lauderdale, Florida, 33308, United States
Unknown Facility
Ft. Pierce, Florida, 34982, United States
Unknown Facility
Miami, Florida, 33133, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Orlando, Florida, 32803-1851, United States
Unknown Facility
Tampa, Florida, 33607, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Macon, Georgia, 31201, United States
Unknown Facility
Savannah, Georgia, 31401, United States
Unknown Facility
Springfield, Massachusetts, 01105, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Newark, New Jersey, 07102, United States
Unknown Facility
Great Neck, New York, 11021, United States
Unknown Facility
The Bronx, New York, 10467, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Huntersville, North Carolina, 28078, United States
Unknown Facility
Bellaire, Texas, 77401, United States
Unknown Facility
Dallas, Texas, 75208, United States
Unknown Facility
Dallas, Texas, 75219, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Harlingen, Texas, 78550, United States
Unknown Facility
Houston, Texas, 77004, United States
Unknown Facility
Santo Domingo, 10514, Dominican Republic
Unknown Facility
Santo Domingo, Dominican Republic
Unknown Facility
San Juan, 00909-1711, Puerto Rico
Unknown Facility
Barnaul, 656010, Russia
Unknown Facility
Irkutsk, 664043, Russia
Unknown Facility
Khabarovsk, 680031, Russia
Unknown Facility
Krasnodar, 350015, Russia
Unknown Facility
Krasnoyarsk, 660049, Russia
Unknown Facility
Lipetsk, 398043, Russia
Unknown Facility
Moscow, 105275, Russia
Unknown Facility
Moscow, 129110, Russia
Unknown Facility
Nizhny Novgorod, 603950, Russia
Unknown Facility
Saint Petersburg, 190103, Russia
Unknown Facility
Saint Petersburg, 191167, Russia
Unknown Facility
Saint Petersburg, 196645, Russia
Unknown Facility
Saint-Petersberg, 190020, Russia
Unknown Facility
Volgograd, 400010, Russia
Unknown Facility
Voronezh, 394065, Russia
Unknown Facility
Yekaterinburg, 620102, Russia
Unknown Facility
Коltsovo, 630559, Russia
Unknown Facility
Bangkok, 10330, Thailand
Unknown Facility
Bangkok, 10400, Thailand
Unknown Facility
Bangkok, 10700, Thailand
Unknown Facility
Chiang Mai, 50200, Thailand
Unknown Facility
Khon Kaen, 40002, Thailand
Unknown Facility
Nonthaburi, 11000, Thailand
Unknown Facility
Kampala, Uganda
Related Publications (2)
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.
PMID: 36912172DERIVEDKityo 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.
PMID: 31609930DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2016
First Posted
January 12, 2016
Study Start
February 19, 2016
Primary Completion
October 9, 2017
Study Completion
November 26, 2018
Last Updated
March 4, 2020
Results First Posted
November 2, 2018
Record last verified: 2019-11
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.