Randomized study of the tolerance and efficacy of high- versus low-dose zidovudine in human immunodeficiency virus-infected children with mild to moderate symptoms (AIDS Clinical Trials Group 128). Pediatric AIDS Clinical Trials Group

J Infect Dis. 1996 May;173(5):1097-106. doi: 10.1093/infdis/173.5.1097.


The current dosage of zidovudine for children is 180 mg/m2 every 6 h. To investigate whether a lower dosage was equally effective, human immunodeficiency virus (HIV)-infected children (3 months to 12 years) with mild to moderate symptoms were randomly assigned to receive either high-dose (180 mg/m2/dose) or low-dose (90 mg/m2/dose) zidovudine (double-blind). Treatments were compared with respect to neuropsychologic function, survival, clinical and laboratory evidence of disease progression, and safety and tolerance. Four hundred twenty-six HIV-infected children were enrolled; median time for receipt of study drug was 35 months. Zidovudine in either dose was well tolerated, with no difference in efficacy or tolerance by treatment group using any clinical or laboratory parameter. In children with mild to moderate disease, a reduction of zidovudine to 90 mg/m2/dose will result in substantial cost savings and should be the recommended dose.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS Dementia Complex / drug therapy
  • AIDS Dementia Complex / mortality
  • AIDS Dementia Complex / psychology
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects
  • Child
  • Child, Preschool
  • Disease Progression
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • HIV Core Protein p24 / blood
  • HIV Infections / drug therapy*
  • HIV Infections / mortality
  • HIV Infections / psychology
  • Humans
  • Infant
  • Liver / physiopathology
  • Male
  • Neuropsychological Tests
  • Zidovudine / administration & dosage*
  • Zidovudine / adverse effects


  • Antiviral Agents
  • HIV Core Protein p24
  • Zidovudine