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

Completed · Not applicable

Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections

In brief

The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.

Key facts

Study ID

NCT00002032

Run by

Pharmacia

People needed

750

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Ctr for Special Immunology — Irvine, California, United States
• Olive View Med Ctr — Sylmar, California, United States
• Denver Public Health Dept — Denver, Colorado, United States
• Veterans Administration Med Ctr — Washington D.C., District of Columbia, United States
• Ctr for Special Immunology — Fort Lauderdale, Florida, United States
• TheraFirst Med Ctrs Inc — Fort Lauderdale, Florida, United States
• Mem Hosp Hollywood — Hollywood, Florida, United States
• VP Med Services / HHCS Research Institute Inc — Orlando, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Grady Memorial Hosp / Hughs Spalding Med Ctr — Atlanta, Georgia, United States
• Dr Winkler Weinberg — Roswell, Georgia, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• CRI of New England — Brookline, Massachusetts, United States
• Univ of Missouri at Kansas City School of Medicine — Kansas City, Missouri, United States
• Research Med Ctr — Kansas City, Missouri, United States
• Brooklyn Veterans Administration — Brooklyn, New York, United States
• Maimonides Med Ctr — Brooklyn, New York, United States
• Nassau County Med Ctr — East Meadow, New York, United States
• Long Island Jewish Med Ctr — New Hyde Park, New York, United States
• Community Research Initiative — New York, New York, United States
• Chelsea Village Med Ctr — New York, New York, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
• Univ Hosp of Cleveland / Case Western Reserve Univ — Cleveland, Ohio, United States
• Ohio State Univ Med Ctr — Columbus, Ohio, United States
• Central Texas Med Foundation — Austin, Texas, United States

Full record on ClinicalTrials.gov

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