Inclusion Criteria
Concurrent Medication:
Allowed:
- Antimicrobial agents not specifically prohibited.
Concurrent Treatment:
Allowed:
Patients must have:
- HIV positivity.
- Prior PCP (histologically confirmed) OR documented CD4 count < 200 cells/mm3 OR constitutional symptoms such as thrush or unexplained fever (> 100 F) for 2 or more weeks.
- No current or suspected active PCP, and no signs of active PCP on chest x-ray.
- Prior intolerance to TMP/SMX or other trimethoprim or sulfa-containing regimens.
- Life-expectancy of at least 6 months.
NOTE:
- Pregnant women are eligible at the discretion of the investigator.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Significant psychosis or emotional disorder that would preclude study compliance.
- Severe chronic diarrhea (e.g., > five stools/day) that may negatively affect absorption of oral medication.
- Unable to take oral medication or unable or unwilling to take medication with food.
Concurrent Medication:
Excluded:
- Rifampin.
- Other investigational agents except for drugs available through Treatment INDs or expanded access programs.
- Medications likely to have anti-pneumocystis effect (e.g., dapsone, trimethoprim, pyrimethamine, trimetrexate, other DHFR inhibitors, sulfadiazine, sulfamethoxazole, other sulfonamides, primaquine, clindamycin, and sulfonylureas.
- Corticosteroids in greater than physiologic replacement doses for more than 21 consecutive days.
- Systemic therapy for CNS toxoplasmosis, Kaposi's sarcoma, lymphoma, other active malignancies, or other disease that may decrease life expectancy or confound assessment.
Patients with the following prior conditions are excluded:
- History of severe or intractable intolerance to atovaquone or aerosolized pentamidine.
- Prior hypoglycemia, pancreatitis, arrhythmias, or severe hypotension associated with any form of pentamidine.
- Prior enrollment in this protocol. Active substance abuse that would preclude study compliance.
Purpose
