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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Pneumocystis prophylaxis.
• • Antiretroviral therapy, or other experimental protocols.
• • Antipyretics and analgesics as per the treating physician.
• • 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.