An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)
Ethambutol hydrochloride
+ Clarithromycin
+ Clofazimine
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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. Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria 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. Exclusion Criteria 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).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 16 locations
Community Consortium of San Francisco
San Francisco, United StatesOpen Community Consortium of San Francisco in Google MapsDenver CPCRA / Denver Public Hlth
Denver, United StatesVeterans Administration Med Ctr / Regional AIDS Program
Washington D.C., United StatesAIDS Research Consortium of Atlanta
Atlanta, United States