NCT02652624

Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF) or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumarate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: Female
• 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 elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	E/C/F/TAF	150/150/200/10 mg FDC tablet administered orally once daily with food
DRUG	E/C/F/TDF	150/150/200/300 mg FDC administered orally once daily with food
DRUG	ATV	ATV 300 mg capsules administered orally once daily with food
DRUG	RTV	RTV 100 mg tablets administered orally once daily with food
DRUG	FTC/TDF	200/300 mg tablet administered orally once daily with food
DRUG	B/F/TAF	50/200/25 mg FDC tablet administered orally once daily without regard to food

Timeline

• Start date: 2016-02-19
• Primary completion: 2017-10-09
• Completion: 2018-11-26
• First posted: 2016-01-12
• Last updated: 2020-03-04
• Results posted: 2018-11-02

Locations

56 sites across 6 countries: United States, Dominican Republic, Puerto Rico, Russia, Thailand, Uganda

Regulatory

• FDA-regulated drug study