Conditions: HIV Infections
Keywords: Phase 3 Randomized, Open-Label Treatment-Experienced Highly Active Antiretroviral Therapy HIV Tenofovir DF Pediatrics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 97
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Tenofovir DF intervention 2: Zidovudine intervention 3: Stavudine
Intervention descriptions: intervention 1: 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. intervention 2: 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). intervention 3: 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).

Protocol document: