153
Participants
Start Date
September 17, 2007
Primary Completion Date
June 3, 2013
Study Completion Date
May 18, 2017
Raltegravir poloxamer film coated tablet
Final Selected Dose: 400-mg tablet taken orally twice daily.
Raltegravir chewable tablet
Final Selected Dose: Weight based dose of \~6 mg/kg according to the dosing table, to a maximum dose of 300 mg, taken orally twice daily.
Raltegravir oral granules for suspension (20 mg/mL)
Weight based dose of \~6 mg/kg orally every 12 hours according to dosing table in protocol or the dose determined by review of all available data.
Raltegravir poloxamer film coated tablet
Final Selected Dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg. Participants \< 25 kg were switched to a weight-based dose of the chewable tablet.
Soweto IMPAACT CRS, Johannesburg
Shandukani Research CRS, Johannesburg
Durban Paediatric HIV CRS, Durban
Family Clinical Research Unit (FAM-CRU) CRS, Tygerberg
Nyu Ny Nichd Crs, New York
Metropolitan Hosp. NICHD CRS, New York
Columbia IMPAACT CRS, New York
Bronx-Lebanon Hospital Center NICHD CRS, The Bronx
Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx
Philadelphia IMPAACT Unit CRS, Philadelphia
Children's National Med. Ctr. Washington DC NICHD CRS, Washington D.C.
Howard Univ. Washington DC NICHD CRS, Washington D.C.
Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore
DUMC Ped. CRS, Durham
Univ. of Florida Jacksonville NICHD CRS, Jacksonville
South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale
USF - Tampa NICHD CRS, Tampa
Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago
Tulane Univ. New Orleans NICHD CRS, New Orleans
Univ. of Colorado Denver NICHD CRS, Aurora
Usc La Nichd Crs, Alhambra
Univ. of California San Francisco NICHD CRS, San Francisco
Seattle Children's Research Institute CRS, Seattle
University of California, UC San Diego CRS, La Jolla
Children's Hospital of Los Angeles NICHD CRS, Los Angeles
David Geffen School of Medicine at UCLA NICHD CRS, Los Angeles
Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS, Chicago
Children's Hosp. of Boston NICHD CRS, Boston
Boston Medical Center Ped. HIV Program NICHD CRS, Boston
WNE Maternal Pediatric Adolescent AIDS CRS, Worcester
SUNY Stony Brook NICHD CRS, Stony Brook
St. Jude Children's Research Hospital CRS, Memphis
Texas Children's Hospital CRS, Houston
Hosp. General de Agudos Buenos Aires Argentina NICHD CRS, Ciudad de Buenos Aires
Gaborone CRS, Gaborone
SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte
Hospital Nossa Senhora da Conceicao NICHD CRS, Porto Alegre
Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS, Rio de Janeiro
Inst de Infectologia Emilio Ribas Sao Paulo Brazil NICHD CRS, São Paulo
Univ. of Sao Paulo Brazil NICHD CRS, São Paulo
San Juan City Hosp. PR NICHD CRS, San Juan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH