NCT02607956

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	DTG	50 mg tablets administered orally, once daily
DRUG	F/TAF	200/25 mg tablets administered orally, once daily
DRUG	B/F/TAF	50/200/25 milligrams (mg) FDC tablets administered orally, once daily
DRUG	DTG Placebo	Tablets administered orally, once daily
DRUG	F/TAF Placebo	Tablets administered orally, once daily
DRUG	B/F/TAF Placebo	Tablets administered orally, once daily

Timeline

• Start date: 2015-11-11
• Primary completion: 2017-05-12
• Completion: 2021-07-05
• First posted: 2015-11-18
• Last updated: 2022-03-07
• Results posted: 2018-06-06

Locations

125 sites across 11 countries: United States, Australia, Belgium, Canada, Dominican Republic, France, Germany, Italy, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study