Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
Mycobacterium Avium-intracellulare Infection, HIV Infections
About this trial
This is an interventional treatment trial for Mycobacterium Avium-intracellulare Infection focused on measuring Rifabutin, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Antitubercular Agents
Eligibility Criteria
Inclusion Criteria Patients must have the following: Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC). Written informed consent. Females of childbearing potential must also sign a special informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI). Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation. Concurrent Medication: Excluded: Antiretroviral agents other than zidovudine (AZT). Didanosine (ddI). Antimycobacterial therapy. Rifampin. Isoniazid. Clofazimine. Ethambutol. Cycloserine. Ethionamide. Amikacin. Ciprofloxacin. Streptomycin. Other investigational drugs. If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy. Patients with the following are excluded: Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI). Previous or current Mycobacterium avium complex (MAC) infection. Perceived patient unreliability or unavailability for frequent monitoring. Prior Medication: Excluded within 4 weeks of study entry: Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI). Antimycobacterial therapy. Rifampin. Isoniazid. Clofazimine. Ethambutol. Cycloserine. Ethionamide. Amikacin. Ciprofloxacin. Required: Zidovudine (AZT). Antipneumocystis prophylactic therapy. Required for at least 4 weeks prior to study entry: Zidovudine (AZT) or didanosine (ddI). Antipneumocystis prophylaxis.
Sites / Locations
- Ctr for Special Immunology
- Olive View Med Ctr
- Denver Public Health Dept
- Veterans Administration Med Ctr
- Ctr for Special Immunology
- TheraFirst Med Ctrs Inc
- Mem Hosp Hollywood
- VP Med Services / HHCS Research Institute Inc
- AIDS Research Consortium of Atlanta
- Grady Memorial Hosp / Hughs Spalding Med Ctr
- Dr Winkler Weinberg
- Johns Hopkins School of Medicine
- CRI of New England
- Univ of Missouri at Kansas City School of Medicine
- Research Med Ctr
- Brooklyn Veterans Administration
- Maimonides Med Ctr
- Nassau County Med Ctr
- Long Island Jewish Med Ctr
- Community Research Initiative
- Chelsea Village Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Univ Hosp of Cleveland / Case Western Reserve Univ
- Ohio State Univ Med Ctr
- Central Texas Med Foundation
- Nelson Tebedo Community Clinic
- Univ of Texas Southwestern Med Ctr of Dallas
- Texas Tech Health Sciences Ctr
- Baylor College of Medicine
- Houston Clinical Research Network
- Univ TX San Antonio Health Science Ctr
- Scott and White Hosp
- Dr Scott Lea