NCT02603120

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in 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 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

• 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 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 Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

Conditions

• HIV-1 Infection

Interventions

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

Timeline

• Start date: 2015-11-11
• Primary completion: 2017-05-09
• Completion: 2019-10-23
• First posted: 2015-11-11
• Last updated: 2020-11-12
• Results posted: 2018-07-23

Locations

94 sites across 10 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study