CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
Etravirine (TMC125) +1 moredrug
Likely dose
Etravirine (TMC125) 5.2 mg/kgfrom 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/NCT00665847
NCT00665847Phase 2Completed
CompareCT.gov

A Phase II, Open-label Trial, to Evaluate the Safety, Tolerability and Antiviral Activity of TMC125 in Antiretroviral Experienced HIV-1 Infected Children and Adolescents

Tibotec Pharmaceuticals, Ireland·interventional·Posted Apr 24, 2008·Updated Apr 23, 2015

In Brief

A Phase 2 clinical trial evaluating Etravirine (TMC125) and Optimized background regimen (OBR) for HIV-1. Completed, enrolled 103 participants across 42 sites in 13 countries.

Detailed Summary

The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1
CountriesArgentina, Brazil, Canada, France, Netherlands, Portugal, Puerto Rico, Romania, South Africa, Spain, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.2 years ago

Interventions

Etravirine (TMC125)drug

Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks.

Optimized background regimen (OBR)drug

An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir \[LPV\], darunavir \[DRV\], atazanavir \[ATV\] or saquinavir \[SQV\]) in combination with nucleos(t)ide reverse transcriptase inhibitor(s) (N\[t\]RTIs) to be dosed according to the drugs individual package inserts for 48 weeks.