The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Patients are stratified by age, and separate cohorts from each age group receive 1 of 2 single doses of bis-POM PMEA. The lower dose is given to patients ages 3 months through 17 years; if toxicity is ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Asymptomatic or mildly symptomatic HIV infection, with no worse than grade 1 toxicity for any symptoms.
• • Consent of parent or guardian.
• Prior Medication:
• Allowed:
• • IV gammaglobulin and aerosolized pentamidine for PCP prophylaxis.
• • Antiretrovirals if discontinued by 72 hr prior to study entry.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Acute or chronic infections that require treatment during study.
• Concurrent Medication:
• Excluded:
• • Antiretrovirals other than study drug.
• • Other investigational agents.
• • Immunomodulators.
• • HIV-1 vaccines.
• • Glucocorticoids.
• • Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.
• • TMP / SMX and dapsone.
• PER AMENDMENT 8/23/96:
• * Drugs which may affect renal excretion:
• • Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.
• Prior Medication:
• Excluded within 72 hr prior to study entry:
• • Antiretrovirals other than study drug.
• • Other investigational agents.
• • Immunomodulators.
• • HIV-1 vaccines.
• • Glucocorticoids.
• • Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.
• • TMP / SMX and dapsone.
• PER AMENDMENT 8/23/96:
• * Drugs which may affect renal excretion:
• • Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.