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GS-US-380-1844: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safetyand 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

Description

This study will 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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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

  • 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.

Sites

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