The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA (
adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related
differences exist. To ascertain dosages that may be suitable for a multiple-dose evaluation
in this patient population.
Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has
resulted in increased bioavailability in adult patients in clinical trials. However, the
safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and
the direction of the variation is not predictable. This study will assess these parameters of
bis-POM PMEA in children.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)