97
Participants
Start Date
December 28, 2006
Primary Completion Date
April 6, 2009
Study Completion Date
August 16, 2017
Tenofovir DF
Tenofovir DF (oral powder or tablet): 300-mg tablets for participants \> 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to \> 37 kg may be switched from the oral powder to the tenofovir DF tablet.
Zidovudine
Zidovudine as prescribed by the investigator prior to study entry (pediatric participants \< 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).
Stavudine
Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m\^2 every 8 hours; pediatric participants \> 12 years of age: 300 mg twice daily).
St. Christopher's Hospital for Children, Philadelphia
University of Florida, Jacksonville, Jacksonville
Children's Diagnostic and Treatment Center, Inc, Fort Lauderdale
St. Jude Children's Research Hospital, Memphis
Jeffrey Goodman Special Care Clinic, Los Angeles
University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases, Los Angeles
Hospital del Nino, Panama City
Great Ormond Street Hospital, London
Imperial College London, Paediatrics Infectious Diseases, London
Lead Sponsor
Gilead Sciences
INDUSTRY