Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT00002192
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002192
Study Brief:
Protocol Section:
NCT00002192