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.