NCT02397694

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	BIC	75 mg tablet administered orally once daily
DRUG	F/TAF	200/25 mg FDC tablet administered orally once daily
DRUG	DTG	50 mg tablet administered orally once daily
DRUG	BIC Placebo	Tablet administered orally once daily
DRUG	DTG Placebo	Tablet administered orally once daily
DRUG	B/F/TAF	50/200/25 mg FDC tablet administered orally once daily

Timeline

• Start date: 2015-03-23
• Primary completion: 2015-11-30
• Completion: 2019-02-27
• First posted: 2015-03-25
• Last updated: 2020-04-07
• Results posted: 2018-03-27

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study