CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 438 enrolled
Drug / intervention
PI +3 moredrug
Likely dose
FTC/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/NCT01475838
NCT01475838Phase 3Completed
CompareCT.gov

A Phase 3b Randomized, Open-Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

Gilead Sciences·interventional·Posted Nov 21, 2011·Updated Jun 8, 2016

In Brief

A Phase 3 clinical trial evaluating PI, RTV, and 2 other interventions for Acquired Immunodeficiency Syndrome and HIV Infections. Completed, enrolled 438 participants across 99 sites in 12 countries.

Detailed Summary

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcquired Immunodeficiency Syndrome, HIV Infections
CountriesAustria, Belgium, Canada, France, Germany, Italy, Portugal, Puerto Rico, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2011
Enrollment StartNov 1, 2011
Primary CompletionNov 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.6 years ago

Interventions

PIdrug

PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)

RTVdrug

RTV administered according to prescribing information FTC/TDF administered according to prescribing information

FTC/TDFdrug

FTC/TDF (200/300 mg) administered according to prescribing information

Stribilddrug

Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food