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.

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.
• 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.

California
      Olive View Med Ctr, Sylmar,  California,  91342,  United States
      Ctr for Special Immunology, Irvine,  California,  92718,  United States
Colorado
      Denver Public Health Dept, Denver,  Colorado,  80204,  United States
District of Columbia
      Veterans Administration Med Ctr, Washington,  District of Columbia,  20422,  United States
Florida
      Ctr for Special Immunology, Fort Lauderdale,  Florida,  33308,  United States
      Mem Hosp Hollywood, Hollywood,  Florida,  33021,  United States
      VP Med Services / HHCS Research Institute Inc, Orlando,  Florida,  32806,  United States
      TheraFirst Med Ctrs Inc, Fort Lauderdale,  Florida,  33308,  United States
Georgia
      Grady Memorial Hosp / Hughs Spalding Med Ctr, Atlanta,  Georgia,  30335,  United States
      Dr Winkler Weinberg, Roswell,  Georgia,  30076,  United States
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Maryland
      Johns Hopkins School of Medicine, Baltimore,  Maryland,  21205,  United States
Massachusetts
      CRI of New England, Brookline,  Massachusetts,  02445,  United States
Missouri
      Univ of Missouri at Kansas City School of Medicine, Kansas City,  Missouri,  64108,  United States
      Research Med Ctr, Kansas City,  Missouri,  64132,  United States
New York
      Nassau County Med Ctr, East Meadow,  New York,  11554,  United States
      Brooklyn Veterans Administration, Brooklyn,  New York,  11209,  United States
      Chelsea Village Med Ctr, New York,  New York,  10014,  United States
      Maimonides Med Ctr, Brooklyn,  New York,  11219,  United States
      Community Research Initiative, New York,  New York,  10011,  United States
      Long Island Jewish Med Ctr, New Hyde Park,  New York,  11042,  United States
      Mem Sloan - Kettering Cancer Ctr, New York,  New York,  10021,  United States
Ohio
      Ohio State Univ Med Ctr, Columbus,  Ohio,  43210,  United States
      Univ Hosp of Cleveland / Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States
Texas
      Univ TX San Antonio Health Science Ctr, San Antonio,  Texas,  78284,  United States
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
      Nelson Tebedo Community Clinic, Dallas,  Texas,  75219,  United States
      Dr Scott Lea, Waco,  Texas,  76708,  United States
      Scott and White Hosp, Temple,  Texas,  76508,  United States
      Texas Tech Health Sciences Ctr, El Paso,  Texas,  79905,  United States
      Baylor College of Medicine, Houston,  Texas,  77005,  United States
      Houston Clinical Research Network, Houston,  Texas,  77266,  United States
      Central Texas Med Foundation, Austin,  Texas,  78751,  United States

Study ID Numbers:  048A; 087023-999
Record last reviewed:  January 1992
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002032
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08