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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:February 19, 2016
End Date:November 26, 2018

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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

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.


Key Inclusion Criteria

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
27
sites
2178
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Atlanta, GA
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1889
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from 98109
Bellaire, TX
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from 98109
Bronx, NY
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Charlotte, North Carolina 28207
2283
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from 98109
Charlotte, NC
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1682
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from 98109
Dallas, TX
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1682
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from 98109
Dallas, TX
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2181
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from 98109
Decatur, GA
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2341
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from 98109
Durham, NC
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2717
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from 98109
Fort Lauderdale, FL
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2645
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from 98109
Fort Pierce, FL
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1660
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from 98109
Fort Worth, TX
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2412
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from 98109
Great Neck, NY
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1994
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from 98109
Harlingen, TX
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1890
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from 98109
Houston, TX
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Huntersville, North Carolina 28078
2274
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from 98109
Huntersville, NC
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2255
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from 98109
Macon, GA
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2730
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from 98109
Miami, FL
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2393
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from 98109
Newark, NJ
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2544
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from 98109
Orlando, FL
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1720
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from 98109
Saint Louis, MO
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3550
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from 98109
Santo Domingo,
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2404
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from 98109
Savannah, GA
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Springfield, Massachusetts 01199
2423
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from 98109
Springfield, MA
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2412
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from 98109
Stamford, CT
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2527
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from 98109
Tampa, FL
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2322
mi
from 98109
Washington,
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2692
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from 98109
West Palm Beach, FL
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