At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 503 enrolled
Drug / intervention
TMC125drug
Likely dose
TMC125 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.
An Open-label Trial With TMC125 as Part of an ART Including TMC114/Rtv and an Investigator-selected OBR in HIV-1 Infected Subjects Who Participated in a DUET Phase III Trial (TMC125-C206 or TMC125-C216).
In Brief
A Phase 3 clinical trial evaluating TMC125 for HIV-1. Completed, enrolled 503 participants across 72 sites in 14 countries.
Detailed Summary
The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Mexico, Panama, Puerto Rico, Spain, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedAug 2006
Primary CompletionJan 2012
TodayJul 2026
First PostedAug 1, 2006
Enrollment StartJun 1, 2006
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 19.9 years ago
Interventions
TMC125drug
200 mg twice daily until commercially available