Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Tenofovir DF; Zidovudine; Stavudine
Intervention description: 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 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 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).
Intervention MeSH terms: Tenofovir; Zidovudine; Stavudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 2 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Phase 3; Randomized, Open-Label; Treatment-Experienced; Highly Active Antiretroviral Therapy; HIV; Tenofovir DF; Pediatrics

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.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Documented laboratory diagnosis of HIV-1 infection

          -  Plasma HIV-1 RNA < 400 copies/mL

          -  Currently on a stable stavudine or zidovudine -containing antiretroviral therapy
             regimen for at least 12 weeks

          -  Naive to tenofovir DF

        Key Inclusion Criteria for the First 96-Week Extension

          -  Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study

          -  <18 years of age (at the start of the extension)

          -  Participants initially randomized to Arm 2 will be given the option to replace
             stavudine or zidovudine with tenofovir DF in the 96-week extension at the
             investigator's discretion, if the investigator determines that tenofovir DF is safe
             and beneficial for the participant.

        Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended
        Extension

          -  Completed of treatment with study drug in the first extension phase

          -  <18 years of age at the start of the extension. This inclusion criterion is not
             applicable in those regions where tenofovir DF is not commercially available for
             treatment of HIV-1 infection in adults.

        Key Exclusion Criteria:

          -  Participants receiving ongoing therapy with any of the following

          -  Nephrotoxic agents

          -  Systemic chemotherapeutic agents

          -  Systemic corticosteroids

          -  Interleukin 2 (IL 2) and other immunomodulating agents

          -  Investigational agents

          -  Pregnant or lactating participants

          -  Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting
             which may confer an inability to receive an orally administered medication

          -  Current alcohol or substance abuse judged by the investigator to potentially interfere
             with participant compliance

          -  Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic therapy within 15 days prior to screening

          -  Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis,
             polycystic kidney disease, congenital nephrosis)

          -  Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis,
             osteogenesis imperfecta, osteochondroses, multiple bone fractures)

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.