Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
2–15
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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.
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.
You may not be if
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)
Clareo Health | Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
