A Phase IA Single Dose Pharmacokinetics and Safety Study of the Oral Antiviral Compound, 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) (Adefovir Dipivoxil) in Children With HIV-1 Infection

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety