Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS
Completed · Phase 3
Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections
In brief
To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients. Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
Key facts
- Study ID
- NCT00001047
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 400
- Expected to finish
- 1996-08-01
- Last updated by the study team
- 2021-11-04
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Recommended in patients with CD4 count <= 200 cells/mm3:
- Antiretroviral therapy.
- PCP prophylaxis.
- Allowed in all patients:
- Isoniazid preventive therapy.
- Patients must have:
- HIV infection.
- Evidence of disseminated MAC infection.
- NOTE:
- Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity to the study drugs.
- Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis.
- Concurrent Medication:
- Excluded:
- Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen).
- Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).
Where it is running
- Community Consortium of San Francisco — San Francisco, California, United States
- Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
- Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
- AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
- AIDS Research Alliance - Chicago — Chicago, Illinois, United States
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
- Baltimore Trials — Baltimore, Maryland, United States
- Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
- Henry Ford Hosp — Detroit, Michigan, United States
- Southern New Jersey AIDS Cln Trials / Dept of Med — Camden, New Jersey, United States
- North Jersey Community Research Initiative — Newark, New Jersey, United States
- Partners Research — Albuquerque, New Mexico, United States
- Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
- Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
- Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
- Richmond AIDS Consortium — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.