NCT01968551

Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (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 elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.

Conditions

• HIV-1
• HIV Infections
• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
DRUG	E/C/F/TAF	150/150/200/10 mg FDC tablet administered orally once daily
DRUG	DRV	800 mg tablet administered orally once daily
DRUG	Baseline DRV- containing ARV regimen	Participants will take their baseline DRV- containing ARV regimen as prescribed.

Timeline

• Start date: 2013-09-03
• Primary completion: 2015-07-21
• Completion: 2016-07-09
• First posted: 2013-10-24
• Last updated: 2018-11-16
• Results posted: 2016-11-01

Locations

62 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study