NCT02603107

Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 578 (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 to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	RTV	100 mg capsule coadministered orally with ATV or DRV once daily with food
DRUG	ATV	300 mg capsule administered orally once daily with food
DRUG	DRV	800 mg tablet administered orally once daily with food
DRUG	COBI	150 mg tablet coadministered orally with ATV or DRV once daily with food
DRUG	ATV/co	300/150 mg FDC tablet administered orally once daily with food
DRUG	DRV/co	800/150 mg FDC tablet administered orally once daily with food
DRUG	FTC/TDF	200/300 mg FDC tablet administered orally once daily without regard to food
DRUG	ABC/3TC	600/300 mg tablet administered orally once daily with or without regard to food
DRUG	B/F/TAF	50/200/25 mg FDC tablet administered orally once daily without regard to food

Timeline

• Start date: 2015-11-20
• Primary completion: 2017-05-15
• Completion: 2019-12-23
• First posted: 2015-11-11
• Last updated: 2020-12-29
• Results posted: 2018-06-06

Locations

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

Regulatory

• FDA-regulated drug study