Evaluation of the Safety, Tolerance and Pharmacokinetics of Rifabutin/Clarithromycin Combination and Rifabutin/Azithromycin Combination in HIV-Infected Patients

Inclusion Criteria Concurrent Medication: Allowed: Primary or secondary PCP prophylaxis with TMP/SMX, dapsone, or aerosolized pentamidine. Any approved therapy for antiretroviral treatment, or antiretroviral therapy available through FDA-sanctioned treatment IND or treatment protocol. Patients must have: AMENDED (PART B): Either HIV infection OR no HIV infection. CD4 count unspecified. ORIGINAL: Documented HIV infection. CD4 count < 200 cells/mm3 within 90 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Known Mycobacterium avium-intracellulare (MAI) bacteremia or presence of a clinical syndrome compatible with MAI (i.e., fevers, weight loss, elevated LDH and alkaline phosphatase). Fever = or > 38.5 deg C (100.4 deg F) within 7 days prior to study entry. Concurrent Medication: Excluded: Acute or chronic use of phenobarbital, carbamazepine, rifampin, dilantin, fluconazole, itraconazole, ketoconazole, ciprofloxacin, beta-blockers, or clarithromycin. Oral contraceptives. Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection. Maintenance therapy for CMV, cryptococcal meningitis, or toxoplasmosis. Cytotoxic chemotherapy. Patients with the following prior conditions are excluded: History of intolerance or hypersensitivity to study drugs, other macrolide antibiotics, or rifampin. Three or more loose bowel movements per day within 3 months prior to study entry. Unintentional weight loss >= 5 percent of body weight within 3 months prior to study entry. Prior Medication: Excluded: Rifabutin within 30 days prior to study entry. Clarithromycin or azithromycin within 14 days prior to study entry. Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection within 28 days prior to study entry. Prior Treatment: Excluded: Blood transfusions within 1 month prior to study entry.