Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

PHASE3CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

December 28, 2006

Primary Completion Date

April 6, 2009

Study Completion Date

August 16, 2017

Conditions
HIV Infections
Interventions
DRUG

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.

DRUG

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).

DRUG

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).

Trial Locations (9)

19134

St. Christopher's Hospital for Children, Philadelphia

32209

University of Florida, Jacksonville, Jacksonville

33316

Children's Diagnostic and Treatment Center, Inc, Fort Lauderdale

38105

St. Jude Children's Research Hospital, Memphis

90027

Jeffrey Goodman Special Care Clinic, Los Angeles

90095

University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases, Los Angeles

Unknown

Hospital del Nino, Panama City

Great Ormond Street Hospital, London

Imperial College London, Paediatrics Infectious Diseases, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT00528957 - Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children | Biotech Hunter | Biotech Hunter