CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Etravirine (ETR)drug
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/NCT01504841
NCT01504841Phase 2Completed
CompareCT.gov

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral (ARV) Treatment-Experienced HIV-1 Infected Infants and Children, Aged ≥ 2 Months to < 6 Years

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 5, 2012·Updated Nov 2, 2021

In Brief

A Phase 2 clinical trial evaluating Etravirine (ETR) for HIV Infections. Completed, enrolled 26 participants across 11 sites in 3 countries.

Detailed Summary

Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are widely used as part of combination antiretroviral therapy (ART) for infants and children, but NNRTI resistance is increasing, leading to treatment failure. This study tested the safety, tolerability, and dosing levels of etravirine (ETR), a new NNRTI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, South Africa, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 5, 2012
Enrollment StartMar 14, 2013
Primary CompletionJul 17, 2018
Study CompletionAug 26, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 14.5 years ago

Interventions

Etravirine (ETR)drug

ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.