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 |
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.
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
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