Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children

Inclusion Criteria

Concurrent Medication:

Allowed:

• Zidovudine (AZT).
• Dideoxycytidine (zalcitabine; ddC).
• Didanosine (ddI).
• Nonaminoglycoside, nonmacrolide, and nonsulfonamide antibiotics.
• Factor VIII.
• IVIG.

Patients must have:

• AIDS, documented HIV infection, perinatal exposure to HIV, or risk of developing PCP.
• Normal EKG and chest radiograph.
• No blood or protein on urinalysis.
• Consent of parent or guardian.

Prior Medication:

Allowed:

• Prophylactic TMP/SMX if given no less than 3 days prior to study entry.
• Prophylactic aerosolized pentamidine (or a single intravenous dose of 4.0 mg/kg pentamidine) if given no less than 7 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Anticipated organ system or laboratory abnormalities (other than immune system abnormalities) from the primary disease and its treatment during the study.
• Acute or chronic infections requiring treatment during the study. NOTE:
• Thrush and herpes labialis are allowed if these conditions do not require treatment.
• Diarrhea or vomiting.

Concurrent Medication:

Excluded:

• Trimethoprim/sulfamethoxazole.
• Sulfadoxine and pyrimethamine (Fansidar).
• Primaquine.
• Aspirin.
• Amphotericin B.
• Aminoglycoside antibiotics.
• Sulfonamides.
• Dapsone.
• Benzodiazepines.
• Rifampin.
• Erythromycin, clarithromycin, and azithromycin.
• Digitalis.
• Para-aminosalicylic acid (PAS).
• Isoniazid.
• Anticoagulants.
• Any other investigational therapies.

Patients with the following prior condition are excluded:

• History of G6PD deficiency.

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