CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 583 enrolled
Drug / intervention
E/C/F/TDF +8 moredrug
Likely dose
E/C/F/TDF 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01705574
NCT01705574Phase 3Completed
CompareCT.gov

A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women

Gilead Sciences·interventional·Posted Oct 12, 2012·Updated Sep 20, 2019

In Brief

A Phase 3 clinical trial evaluating E/C/F/TDF, ATV, and 7 other interventions for Acquired Immunodeficiency Syndrome and HIV Infections. Completed, enrolled 583 participants across 99 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcquired Immunodeficiency Syndrome, HIV Infections
CountriesBelgium, Dominican Republic, France, Italy, Mexico, Portugal, Puerto Rico, Russia, Thailand, Uganda, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2012
Enrollment StartOct 24, 2012
Primary CompletionFeb 9, 2015
Study CompletionSep 6, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.7 years ago

Interventions

E/C/F/TDFdrug

150/150/200/300 mg FDC tablet administered orally with food once daily

ATVdrug

300 mg capsule administered orally with food once daily

RTVdrug

100 mg tablet administered orally with food once daily

FTC/TDFdrug

200/300 mg tablet administered orally with food once daily

E/C/F/TDF Placebodrug

Tablet administered orally with food once daily

ATV Placebodrug

Tablet administered orally with food once daily

RTV Placebodrug

Capsule administered orally with food once daily

FTC/TDF Placebodrug

Tablet administered orally with food once daily

E/C/F/TAFdrug

150/150/200/10 mg FDC tablet administered orally with food once daily