A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following are excluded:
• •Unexplained fever.
• •Night sweats.
• •Unexplained anemia with hemoglobin \< 10 g percent or hematocrit less than 30 percent.
• •Hepatic transaminase elevations or total bilirubin values of \> 3 times normal.
• •Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin.
• •Patients with the following are excluded:
• •Known hypersensitivity to clofazimine.
• •Mycobacterium avium complex (MAC) infection diagnosis at any site (except isolation from stool in asymptomatic patient).
• •Any of the following symptoms at the time of study entry:
• •Unexplained fever.
• •Night sweats.
• •Unexplained anemia with hemoglobin \< 10 percent or hematocrit less than 30 percent.
• •Hepatic transaminase elevations or total bilirubin values of \> 3 times normal.
• •Long-term (over 2 weeks) treatment with any drug with known significant anti-MAC activity.
• •Prior Medication:
• •Excluded:
• •Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin.
• •Group 1:
• •AIDS patients with a first episode of Pneumocystis carinii pneumonia (PCP) within 2 to 4 months prior to study entry.
• •Group 2:
• •Patients with T4 counts \< 100 cells/mm3, regardless of prior opportunistic infections or malignancies.
• •Karnofsky = or \> 70.
• •All patients must sign informed consent.