Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
NCT01705574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 583
Last updated 2019-09-20
Summary
The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.
Conditions
- Acquired Immunodeficiency Syndrome
- HIV Infections
Interventions
- DRUG
-
E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally with food once daily
- DRUG
-
ATV
300 mg capsule administered orally with food once daily
- DRUG
-
RTV
100 mg tablet administered orally with food once daily
- DRUG
-
FTC/TDF
200/300 mg tablet administered orally with food once daily
- DRUG
-
E/C/F/TDF Placebo
Tablet administered orally with food once daily
- DRUG
-
ATV Placebo
Tablet administered orally with food once daily
- DRUG
-
RTV Placebo
Capsule administered orally with food once daily
- DRUG
-
FTC/TDF Placebo
Tablet administered orally with food once daily
- DRUG
-
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally with food once daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-24
- Primary Completion
- 2015-02-09
- Completion
- 2018-09-06
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Dominican Republic
- France
- Italy
- Mexico
- Portugal
- Puerto Rico
- Russia
- Thailand
- Uganda
- United Kingdom
Study Locations
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