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Completed Phase 1Phase 2 Interventional Results available

Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children

ClinicalTrials.gov ID: NCT01504841

Public ClinicalTrials.gov record NCT01504841. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT01504841
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Enrollment
26 participants

Conditions and interventions

Conditions

Interventions

  • Etravirine (ETR) Drug

Drug

Eligibility (public fields only)

Age range
2 Months to 6 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 13, 2013
Primary completion
Jul 16, 2018
Completion
Aug 25, 2020
Last update posted
Nov 1, 2021

2013 – 2020

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Pediatric Perinatal HIV Clinical Trials Unit CRS Miami Florida 33136
Lurie Children's Hospital of Chicago (LCH) CRS Chicago Illinois 60614-3393
Bronx-Lebanon Hospital Center NICHD CRS The Bronx New York 10457
Jacobi Med. Ctr. Bronx NICHD CRS The Bronx New York 10461

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01504841, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 1, 2021 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01504841 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →