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.

Condition	Treatment or Intervention
Mycobacterium avium-intracellulare Infection HIV Infections	Drug: Rifabutin

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 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.

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.

Arizona
      Maricopa County Med Ctr, Phoenix,  Arizona,  85010,  United States
California
      San Francisco Veterans Administration Med Ctr, San Francisco,  California,  94121,  United States
      Dr Jeffrey Galpin, Tarzana,  California,  91356,  United States
      Pacific Oaks Med Group, Beverly Hills,  California,  90211,  United States
      Dr Larry A Waites, San Francisco,  California,  94108,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94704,  United States
      Saint Francis Mem Hosp / HIV Care, San Francisco,  California,  94109,  United States
      Dr Marcus Conant, San Francisco,  California,  94115,  United States
      Dr Marshall Kubota, Santa Rosa,  California,  95404,  United States
      AIDS Community Research Consortium, Redwood City,  California,  94063,  United States
      HIV Research Group, San Diego,  California,  92102,  United States
Florida
      Community Research Initiative of South Florida, Miami,  Florida,  33137,  United States
      Miami Veterans Administration Med Ctr, Miami,  Florida,  33125,  United States
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States
Louisiana
      Tulane Univ School of Medicine, New Orleans,  Louisiana,  70112,  United States
Michigan
      Comprehensive AIDS Alliance of Detroit / Harper Hosp, Detroit,  Michigan,  48201,  United States
Minnesota
      Univ of Minnesota, Minneapolis,  Minnesota,  55455,  United States
      St Paul Ramsey Med Ctr, St. Paul,  Minnesota,  55101,  United States
Nevada
      Univ of Nevada / Veterans Administration Med Ctr, Reno,  Nevada,  89520,  United States
New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
New Mexico
      Dr Donald Romig, Sante Fe,  New Mexico,  87501,  United States
      Univ of New Mexico Hlth Sciences Ctr / Dept of Med, Albuquerque,  New Mexico,  87131,  United States
New York
      Albany Veterans Administration, Albany,  New York,  12208,  United States
      Community Health Network, Rochester,  New York,  14620,  United States
      AIDS Services Erie County Med Ctr, Buffalo,  New York,  14215,  United States
Pennsylvania
      Thomas Jefferson Med College, Philadelphia,  Pennsylvania,  19107,  United States
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
South Carolina
      Dr Alfred F Burnside Jr, Columbia,  South Carolina,  29204,  United States
Virginia
      Infectious Disease Physicians Inc, Annandale,  Virginia,  22203,  United States
Wisconsin
      Milwaukee County Med Complex, Milwaukee,  Wisconsin,  53226,  United States
Canada, Alberta
      Univ of Calgary Health Science Ctr, Calgary,  Alberta,  Canada
      Univ of Alberta/Division of Inf Dis/Dept of Med, Edmonton,  Alberta,  Canada
Canada, British Columbia
      Saint Paul's Hosp, Vancouver,  British Columbia,  Canada
Canada, Nova Scotia
      Victoria Gen Hosp, Halifax,  Nova Scotia,  Canada
Canada, Ontario
      Mount Sinai Hosp, Toronto,  Ontario,  Canada
      Ottawa Gen Hosp, Ottawa,  Ontario,  Canada
      Saint Michael's Hosp, Toronto,  Ontario,  Canada
      McMaster Univ Med Ctr, Hamilton,  Ontario,  Canada
      Sunnybrook Health Science Ctr, Toronto,  Ontario,  Canada
Canada, Quebec
      Dr Emil Toma / Hotel Dieu de Montreal, Montreal,  Quebec,  Canada
      Montreal Gen Hosp, Montreal,  Quebec,  Canada
      Montreal Chest Institute, Montreal,  Quebec,  Canada

Study ID Numbers:  048B; 087027-999
Record last reviewed:  March 1992
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002267
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08