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A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS



A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS

For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): Pharmacia ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 200

Location and Contact Information:

AIDS Community Research Consortium
Redwood City,  California,  94063
United States
 

Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles,  California,  90028
United States
 

Dr Frank Rhame
Minneapolis,  Minnesota,  55455
United States
 

Bay Harbor Hosp
Harbor City,  California,  90710
United States
 

Ctr for Special Immunology
Irvine,  California,  92718
United States
 

Milwaukee County Med Complex
Milwaukee,  Wisconsin,  53226
United States
 

Infectious Disease Physicians Inc
Annandale,  Virginia,  22203
United States
 

San Francisco Veterans Administration Med Ctr
San Francisco,  California,  94121
United States
 

TheraFirst Med Ctrs Inc
Ft. Lauderdale,  Florida,  33308
United States
 

Research Med Ctr
Kansas City,  Missouri,  64132
United States
 

Chelsea Village Med Ctr / Saint Vincent's Hosp
New York City,  New York,  10014
United States
 

North Jersey Community Research Initiative
Newark,  New Jersey,  071032842
United States
 

Maricopa County Med Ctr
Phoenix,  Arizona,  85010
United States
 

Nassau County Med Ctr
East Meadow,  New York,  11554
United States
 

Miami Veterans Administration Med Ctr
Miami,  Florida,  33125
United States
 

HIV Research Group
San Diego,  California,  92102
United States
 

Dr Alfred F Burnside Jr
Columbia,  South Carolina,  29204
United States
 

Ctr for Special Immunology
Ft. Lauderdale,  Florida,  33316
United States
 

Davies Med Ctr
San Francisco,  California,  94114
United States
 

Infectious Disease Research Consortium of Georgia
Atlanta,  Georgia,  30076
United States
 

Veterans Administration Med Ctr
Washington D.C.,  District of Columbia,  20422
United States
 

Mem Hosp Hollywood
Hollywood,  Florida,  33021
United States
 


Additional Information:
Study ID Numbers:
  048C;  CS 087065
Study Start Date: 
Record last reviewed: November 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001995

Other Hiv Infections Studies:
1. Effects of MAC Preventive Therapy on Disease-Causing Bacteria in HIV-Infected Patients: A Substudy of CPCRA 048

2. Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Problems in HIV-Infected Patients with Increased CD4 Cells Counts Following Anti-HIV Therapy

3. Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS

4. A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients

5. The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients

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A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS

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