CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 180 enrolled / 180 target
Drug / intervention
Etravirinedrug
Likely dose
Etravirine 200 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/NCT00980538
NCT00980538Phase 3CompletedMonitor (0.9/mo)Completion was 67mo ago

Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects

Janssen Sciences Ireland UC·interventional·Posted Sep 21, 2009·Updated Jun 9, 2026

In Brief

A Phase 3 clinical trial evaluating Etravirine for HIV Infections and HIV-1. Completed, enrolled 180 participants across 29 sites in 11 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible through another source \[example, access program or government program\]), or local standard of care, as appropriate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Brazil, Canada, France, Panama, Puerto Rico, Romania, South Africa, Spain, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2009
Enrollment StartDec 9, 2009
Primary CompletionNov 25, 2020
Study CompletionApr 8, 2026
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 16.8 years ago

Arms & Interventions

Etravirineexperimental

Etravirine Dosed by weight up to a maximum dose of 200 milligram (mg) bid until switched to an etravirine (ETR)-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.

Drug: Etravirine

Interventions

Etravirinedrug

Participants will be dosed with etravirine by weight up to a maximum dose of 200 mg bid until switched to an etravirine-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.