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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Adefovir; Adefovir dipivoxil

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.