Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:March 23, 2015
End Date:February 20, 2019

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

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) +
emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir
(DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also
evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.


Key Inclusion Criteria:

- Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)

- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

- Screening genotype report provided by Gilead Sciences must show sensitivity to
tenofovir (TFV) and FTC

- Adequate renal function as measured by estimated glomerular filtration rate ≥ 70
mL/min according to the Cockcroft-Gault formula

- CD4+ cell count > 200 cells/µL at screening

Key Exclusion Criteria:

- A new AIDS-defining condition diagnosed within the 30 days prior to screening as
defined in the study protocol

- Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post
exposure prophylaxis (PEP)

- Chronic hepatitis B virus (HBV) infection

- Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but
have a documented negative HCV RNA, are eligible)

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline

- Participation in any other clinical trial without prior approval from the sponsor is
prohibited while participating in this trial

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
18
sites
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Annandale, VA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Berkley, MI
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Longview, TX
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials