The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate and compare differences in tolerance and side effects associated with two
      different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other
      goals are to evaluate and compare the degree of change in neurodevelopmental disease and
      determine whether there are differences in the rate and degree of toxicities associated with
      one versus the other dosage.

      AZT has been shown to decrease the death rate and frequency of opportunistic infections in
      certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic
      HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics
      (blood levels) in children have indicated that AZT can be given to children in doses that can
      be tolerated and that can be assumed to be therapeutic. Those currently taking care of
      infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance)
      trial. In addition, given the information learned from studies of adult patients that shows
      effectiveness of AZT at lower doses, experience with an equivalent lower dose in children
      needs to be studied.
    

Detailed description: 
      AZT has been shown to decrease the death rate and frequency of opportunistic infections in
      certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic
      HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics
      (blood levels) in children have indicated that AZT can be given to children in doses that can
      be tolerated and that can be assumed to be therapeutic. Those currently taking care of
      infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance)
      trial. In addition, given the information learned from studies of adult patients that shows
      effectiveness of AZT at lower doses, experience with an equivalent lower dose in children
      needs to be studied.

      All participants are randomized to receive AZT at 1 of 2 doses. Patients are stratified
      according to whether CD4 cell counts are > or < 500 cells/mm3 as well as whether symptoms are
      mild to moderate or if patients have lymphocytic interstitial pneumonitis (LIP). Medication
      is dispensed every other week for the first 8 weeks and monthly until week 104, then either
      monthly or every 3 months. Safety and effectiveness of the treatment program are evaluated at
      6-month intervals to assess whether it is appropriate to continue the study as originally
      designed. Patients are evaluated every 2 weeks for the first 8 weeks, monthly until week 104,
      every 3 months until week 208, and then every 6 months thereafter.
    

Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; Zidovudine