To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

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

Concurrent Medication: Allowed:

• Zidovudine (AZT).
• Didanosine (ddI).

Patients must have the following:

• Diagnosis of AIDS as defined by the CDC.
• Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
• Provide written informed consent.

Prior Medication: Allowed:

• If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
• Required:
• Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition: Patients with the following conditions or symptoms are excluded:

• Known hypersensitivity to any of the study drugs.

Concurrent Medication: Excluded:

• Other therapy for mycobacterial disease.

Patients with the following are excluded:

• Known hypersensitivity to any of the study drugs.

Prior Medication: Excluded within 4 weeks:

• Therapy for mycobacterial disease.
• Antiretroviral drugs, other than zidovudine (AZT) or ddI.
• Investigational drugs, other than ddI.

Arizona
      Maricopa County Med Ctr, Phoenix,  Arizona,  85010,  United States
California
      San Francisco Veterans Administration Med Ctr, San Francisco,  California,  94121,  United States
      Ctr for Special Immunology, Irvine,  California,  92718,  United States
      AIDS Community Research Consortium, Redwood City,  California,  94063,  United States
      Southwest Community Based AIDS Treatment Group - COMBAT, Los Angeles,  California,  90028,  United States
      HIV Research Group, San Diego,  California,  92102,  United States
      Bay Harbor Hosp, Harbor City,  California,  90710,  United States
      Davies Med Ctr, San Francisco,  California,  94114,  United States
District of Columbia
      Veterans Administration Med Ctr, Washington,  District of Columbia,  20422,  United States
Florida
      Miami Veterans Administration Med Ctr, Miami,  Florida,  33125,  United States
      Mem Hosp Hollywood, Hollywood,  Florida,  33021,  United States
      Ctr for Special Immunology, Fort Lauderdale,  Florida,  33316,  United States
      TheraFirst Med Ctrs Inc, Fort Lauderdale,  Florida,  33308,  United States
Georgia
      Infectious Disease Research Consortium of Georgia, Atlanta,  Georgia,  30076,  United States
Minnesota
      Dr Frank Rhame, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Research Med Ctr, Kansas City,  Missouri,  64132,  United States
New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
New York
      Chelsea Village Med Ctr / Saint Vincent's Hosp, New York,  New York,  10014,  United States
      Nassau County Med Ctr, East Meadow,  New York,  11554,  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

Study ID Numbers:  048C; CS 087065
Record last reviewed:  November 1992
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001995
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08