- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002343
A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts <= 100 Cells/mm3
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- Univ of California - Davis Med Ctr / CARES
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
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.
Exclusion Criteria
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: PARALLEL
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Sepsis
- Actinomycetales Infections
- Mycobacterium Infections, Nontuberculous
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Bacteremia
- Mycobacterium avium-intracellulare Infection
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Rifabutin
- Ethambutol
Other Study ID Numbers
- 048E
- CS 087287-000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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