The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients
Mycobacterium Avium-intracellulare Infection, HIV Infections
About this trial
This is an interventional treatment trial for Mycobacterium Avium-intracellulare Infection focused on measuring Rifabutin, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Clarithromycin
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis. Allowed: GM-CSF or G-CSF. Erythropoietin. Therapies (including antiretrovirals) available through expanded access or treatment IND programs. Other non-experimental therapies available by prescription. Antihistamines other than those specifically excluded. Patients must have: Evidence or diagnosis of HIV infection or a history of an AIDS-defining condition by CDC criteria. CD4 count <= 100 cells/mm3 within 90 days prior to study entry. Two baseline blood sample cultures negative for MAC within 30 days of study entry. No suspected disseminated MAC disease, in the opinion of the clinician. NOTE: Patients with elevated GGT and/or triglycerides are allowed. NOTE: Patients may co-enroll on ACTG 081/981/181, ACTG 175, ACTG 204, ACTG 193, ACTG 241, or other acceptable protocols. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known or suspected tuberculous infection or other non-tuberculous mycobacterial infection requiring chemotherapy or chemoprophylaxis (with the exception of isoniazid prophylaxis alone). NOTE: Patients may enroll who successfully completed tuberculosis (TB) treatment and have been off anti-TB drugs for more than 6 months with no symptoms of mycobacterial infection. Active TB. Known hypersensitivity to study drugs. Malabsorption as defined by persistent diarrhea with more than 8 stools per day for > 6 weeks. Concurrent Medication: Excluded: Frequent (more than once per month), repeated, or continuous treatment courses of quinolones, erythromycin, spiramycin, azithromycin, clarithromycin, or clindamycin. Concomitant terfenadine or astemizole. Prior Medication: Excluded: Prophylaxis with azithromycin, clarithromycin, or rifabutin for more than 4 months.
Sites / Locations
- Alabama Therapeutics CRS
- UCLA CARE Center CRS
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- Ucsf Aids Crs
- Howard University Hosp., Div. of Infectious Diseases, ACTU
- Univ. of Miami AIDS CRS
- Univ. of Hawaii at Manoa, Leahi Hosp.
- Chicago Children's CRS
- Northwestern University CRS
- Cook County Hosp. CORE Ctr.
- Rush Univ. Med. Ctr. ACTG CRS
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
- Methodist Hosp. of Indiana
- Univ. of Iowa Healthcare, Div. of Infectious Diseases
- Johns Hopkins Adult AIDS CRS
- Massachusetts General Hospital ACTG CRS
- Bmc Actg Crs
- Beth Israel Deaconess - East Campus A0102 CRS
- Beth Israel Deaconess Med. Ctr., ACTG CRS
- Hennepin County Med. Ctr., Div. of Infectious Diseases
- University of Minnesota, ACTU
- St. Louis ConnectCare, Infectious Diseases Clinic
- Washington U CRS
- Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
- Bronx-Lebanon Hosp. IMPAACT CRS
- SUNY - Buffalo, Erie County Medical Ctr.
- NY Univ. HIV/AIDS CRS
- Memorial Sloan-Kettering Cancer Ctr.
- Beth Israel Med. Ctr. (Mt. Sinai)
- Cornell University A2201
- Univ. of Rochester ACTG CRS
- Unc Aids Crs
- Carolinas HealthCare System, Carolinas Med. Ctr.
- Regional Center for Infectious Disease, Wendover Medical Center CRS
- Univ. of Cincinnati CRS
- Case CRS
- MetroHealth CRS
- The Ohio State Univ. AIDS CRS
- Hosp. of the Univ. of Pennsylvania CRS
- The Children's Hosp. of Philadelphia IMPAACT CRS
- University of Washington AIDS CRS
- Mbeya Med. Research Program, Mbeya Referral Hosp. CRS