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 objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.
Key facts
- Study ID
- NCT00002267
- 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 obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.
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
- Maricopa County Med Ctr — Phoenix, Arizona, United States
- East Bay AIDS Ctr — Berkeley, California, United States
- Pacific Oaks Med Group — Beverly Hills, California, United States
- AIDS Community Research Consortium — Redwood City, California, United States
- HIV Research Group — San Diego, California, United States
- Dr Larry A Waites — San Francisco, California, United States
- Saint Francis Mem Hosp / HIV Care — San Francisco, California, United States
- Dr Marcus Conant — San Francisco, California, United States
- San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
- Dr Marshall Kubota — Santa Rosa, California, United States
- Dr Jeffrey Galpin — Tarzana, California, United States
- Miami Veterans Administration Med Ctr — Miami, Florida, United States
- Community Research Initiative of South Florida — Miami, Florida, United States
- Northwestern Univ Med School — Chicago, Illinois, United States
- AIDS Research Alliance - Chicago — Chicago, Illinois, United States
- Tulane Univ School of Medicine — New Orleans, Louisiana, United States
- Comprehensive AIDS Alliance of Detroit / Harper Hosp — Detroit, Michigan, United States
- Univ of Minnesota — Minneapolis, Minnesota, United States
- St Paul Ramsey Med Ctr — Saint Paul, Minnesota, United States
- Univ of Nevada / Veterans Administration Med Ctr — Reno, Nevada, United States
- North Jersey Community Research Initiative — Newark, New Jersey, United States
- Univ of New Mexico Hlth Sciences Ctr / Dept of Med — Albuquerque, New Mexico, United States
- Dr Donald Romig — Sante Fe, New Mexico, United States
- Albany Veterans Administration — Albany, New York, United States
- AIDS Services Erie County Med Ctr — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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