Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:November 11, 2015
End Date:June 2020

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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

The primary objective of this study is to evaluate the efficacy of switching from a regimen
of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of
abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of
bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC
as the FDC ABC/DTG/3TC in virologically suppressed HIV-1 infected adults.


Key Inclusion Criteria:

- Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec)

- Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for
≥ 3 months prior to the screening visit

- HIV RNA < 50 copies/mL at the screening visit

- Currently on a stable regimen for ≥ 3 months preceding the screening visit with
documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening
visit (or undetectable HIV-1 RNA level according to the local assay being used if the
limit of detection is ≥ 50 copies/mL).

- Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV),
DTG, ABC or 3TC

Key Exclusion Criteria:

- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject study compliance

- Active tuberculosis infection

- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
variceal bleeding)

- Females who are pregnant

- Females who are breastfeeding

- Acute hepatitis in the 30 days prior to study entry

- Chronic Hepatitis B Virus (HBV) infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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