Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.

Launched by ANDERSON CLINICAL RESEARCH · Aug 30, 2001

Keywords

ClinConnect Summary

This open-label, sequential study is conducted in two parts: a monotherapy phase and a combination treatment phase.

In the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy.

In the combination treatment phase, 12 patients each are randomized to one of three arms:

Arm I: Rifapentine (assigned dose level based on monotherapy phase) plus azithromycin.

Arm II: Rifapentine (assigned dose level) plus clarithromycin. Arm III: Rifapentine (assigned dose level) plus ethambutol.

Gender

ALL

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.