NCT03110380

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 567 (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 switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

Conditions

• HIV-1-infection

Interventions

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

Timeline

• Start date: 2017-06-12
• Primary completion: 2018-12-04
• Completion: 2021-02-10
• First posted: 2017-04-12
• Last updated: 2022-01-11
• Results posted: 2019-11-20

Locations

94 sites across 6 countries: United States, Austria, Canada, France, Germany, Puerto Rico

Regulatory

• FDA-regulated drug study