NCT01504841 - Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 14, 2013

Primary Completion Date

July 17, 2018

Study Completion Date

August 26, 2020

Conditions

HIV Infections

Interventions

DRUG

Etravirine (ETR)

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.

Trial Locations (11)

2001

Wits RHI Shandukani Research Centre CRS, Johannesburg

4001

Umlazi CRS, Durban

10457

Bronx-Lebanon Hospital Center NICHD CRS, The Bronx

10461

Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx

26030

Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio de Janeiro

33136

Pediatric Perinatal HIV Clinical Trials Unit CRS, Miami

60614-3393

Lurie Children's Hospital of Chicago (LCH) CRS, Chicago

30.130-100

SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte

20221-903

Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro

21941-612

Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS, Rio de Janeiro

14049-900

Univ. of Sao Paulo Brazil NICHD CRS, São Paulo

All Listed Sponsors

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH