A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
Completed · Phase 4
Conditions studied: Mycobacterium Avium-Intracellulare Infection, HIV Infections
In brief
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
Key facts
- Study ID
- NCT00002343
- Run by
- Pharmacia
- People needed
- 200
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Required:
- AZT, d4T, ddI, or ddC.
- Antipneumocystis prophylaxis.
- Allowed:
- Short course (< 14 days) of ciprofloxacin for acute infections.
- Patients must have:
- AIDS.
- CD4 count <= 100 cells/mm3.
- NO prior or current MAC infection.
- Prior Medication:
- Required:
- Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.
- Allowed:
- Prior rifabutin.
- Prior ethambutol.
- Prior clarithromycin.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Positive tuberculin skin test (PPD > 5 mm).
- Active M. tuberculosis.
- Perceived as unreliable or unavailable for frequent monitoring.
- Concurrent Medication:
- Excluded:
- Other antiretrovirals not specifically allowed.
- All investigational drugs.
- Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (>= 14 days).
- Patients with the following prior conditions are excluded:
- Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.
- Prior Medication:
- Excluded within 4 weeks prior to study entry:
- Rifampin.
- Isoniazid.
- Clofazimine.
- Cycloserine.
- Ethionamide.
- Amikacin.
- Ciprofloxacin.
Where it is running
- Univ of California - Davis Med Ctr / CARES — Sacramento, California, United States
Full record on ClinicalTrials.gov
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