NCT02607930

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 631 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The 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 a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	ABC/DTG/3TC	600/50/300 milligrams (mg) tablets administered orally, once daily
DRUG	B/F/TAF	50/200/25 mg tablets administered orally, once daily, without regard to food
DRUG	ABC/DTG/3TC Placebo	Tablets administered orally, once daily
DRUG	B/F/TAF Placebo	Tablets administered orally, once daily

Timeline

• Start date: 2015-11-13
• Primary completion: 2017-05-09
• Completion: 2021-07-02
• First posted: 2015-11-18
• Last updated: 2022-03-02
• Results posted: 2018-07-23

Locations

121 sites across 10 countries: United States, Belgium, Canada, Dominican Republic, France, Germany, Italy, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study