Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.
Mycobacterium Avium-Intracellulare Infection, HIV Infections
About this trial
This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Antitubercular Agents, Azithromycin, Clarithromycin, Bacteremia, rifapentine
Eligibility Criteria
Inclusion Criteria Patients must have: Documented positive HIV serology status. Documented AIDS. Positive blood culture for MAC from the study-designated microbiology laboratory. NOTE: Patients with presumed MAC bacteremia, as evidenced by positive blood, bone marrow, or liver biopsy culture analyzed locally, may be enrolled pending confirmation. Minimum of two MAC-associated symptoms, defined as >= grade 1 fever; > grade 1 night sweats, fatigue, diarrhea, abdominal pain, or anorexia; or weight loss > 5% reported within 4 weeks prior to study entry. Life expectancy of at least 3 months. Prior Medication: Allowed: MAC prophylaxis with medications other than study drugs (5-day washout period required). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Pulmonary tuberculosis. Infections requiring the use of disallowed medications. Serious diseases that introduce undue risks for adverse reactions to study medication. Concurrent Medication: Excluded: Terfenadine. Treatment for pulmonary TB. Study drugs from an outside source. Medications with anti-MAC activity (i.e., amikacin, ciprofloxacin, clofazimine, rifampin, and rifabutin). Patients with the following prior conditions are excluded: History of hypersensitivity to rifabutin, rifampin, clarithromycin, erythromycin, azithromycin, or ethambutol. Previous episode of uveitis. Prior Medication: Excluded: Prophylactic treatment for MAC with rifabutin or any of the study medications. Azithromycin within the 3 weeks prior to randomization. Any investigational drug during the 4 weeks prior to randomization.
Sites / Locations
- Hampton Roads Med Specialists