At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 724 enrolled

Drug / intervention

Elvitegravir +4 moredrug

Likely dose

Not stated in 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/NCT00708162

NCT00708162Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults

Gilead Sciences·interventional·Posted Jul 2, 2008·Updated May 30, 2016

In Brief

A Phase 3 clinical trial evaluating Elvitegravir, Raltegravir, and 3 other interventions for HIV Infection. Completed, enrolled 724 participants across 180 sites in 14 countries.

Detailed Summary

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV Infection

CountriesAustralia, Belgium, Canada, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Switzerland, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2008

First PostedJul 2008

Primary CompletionDec 2010

Study CompletionApr 2015

TodayJul 2026

First PostedJul 2, 2008

Enrollment StartJul 1, 2008

Primary CompletionDec 1, 2010

Study CompletionApr 1, 2015

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 18 years ago

Interventions

Elvitegravirdrug

Elvitegravir (EVG) tablet administered orally once daily with food

Raltegravirdrug

Raltegravir tablet administered orally twice daily according to prescribing information

EVG placebodrug

Placebo to match elvitegravir administered orally once daily

RAL placebodrug

RAL placebo administered orally twice daily.

Background regimendrug

Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.