CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 192 enrolled
Drug / intervention
EVG +2 moredrug
Likely dose
RTV 100 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/NCT00445146
NCT00445146Phase 2Completed
CompareCT.gov

A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects

Gilead Sciences·interventional·Posted Mar 8, 2007·Updated Apr 25, 2016

In Brief

A Phase 2 clinical trial evaluating EVG, RTV, and 1 other intervention for HIV Infections. Completed, enrolled 192 participants across 48 sites in 2 countries.

Detailed Summary

The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 8, 2007
Enrollment StartFeb 1, 2007
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 19.3 years ago

Interventions

EVGdrug

Elvitegravir (EVG) tablet administered orally once daily with food

RTVdrug

Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food

ARV regimendrug

The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).