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

Use our guide to learn which trials are right for you!

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
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
998
mi
from 43215
Bellaire, TX
Click here to add this to my saved trials
482
mi
from 43215
Bronx, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
430
mi
from 43215
Decatur, GA
Click here to add this to my saved trials
354
mi
from 43215
Durham, NC
Click here to add this to my saved trials
970
mi
from 43215
Fort Lauderdale, FL
Click here to add this to my saved trials
878
mi
from 43215
Fort Pierce, FL
Click here to add this to my saved trials
937
mi
from 43215
Fort Worth, TX
Click here to add this to my saved trials
492
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
1272
mi
from 43215
Harlingen, TX
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Huntersville, North Carolina 28078
336
mi
from 43215
Huntersville, NC
Click here to add this to my saved trials
493
mi
from 43215
Macon, GA
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
468
mi
from 43215
Newark, NJ
Click here to add this to my saved trials
792
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
1676
mi
from 43215
Santo Domingo,
Click here to add this to my saved trials
561
mi
from 43215
Savannah, GA
Click here to add this to my saved trials
Springfield, Massachusetts 01199
563
mi
from 43215
Springfield, MA
Click here to add this to my saved trials
503
mi
from 43215
Stamford, CT
Click here to add this to my saved trials
831
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
328
mi
from 43215
Washington,
Click here to add this to my saved trials
931
mi
from 43215
West Palm Beach, FL
Click here to add this to my saved trials