The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
Status:
Completed
Trial end date:
1994-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)