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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



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

For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): Pharmacia ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 750

Location and Contact Information:

Ctr for Special Immunology
Irvine,  California,  92718
United States
 

Univ of Missouri at Kansas City School of Medicine
Kansas City,  Missouri,  64108
United States
 

Community Research Initiative
New York City,  New York,  10011
United States
 

Denver Public Health Dept
Denver,  Colorado,  80204
United States
 

Ctr for Special Immunology
Ft. Lauderdale,  Florida,  33308
United States
 

Brooklyn Veterans Administration
Brooklyn,  New York,  11209
United States
 

Mem Hosp Hollywood
Hollywood,  Florida,  33021
United States
 

Ohio State Univ Med Ctr
Columbus,  Ohio,  43210
United States
 

Mem Sloan - Kettering Cancer Ctr
New York City,  New York,  10021
United States
 

Chelsea Village Med Ctr
New York City,  New York,  10014
United States
 

Maimonides Med Ctr
Brooklyn,  New York,  11219
United States
 

Nelson Tebedo Community Clinic
Dallas,  Texas,  75219
United States
 

Scott and White Hosp
Temple,  Texas,  76508
United States
 

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

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

Olive View Med Ctr
Sylmar,  California,  91342
United States
 

VP Med Services / HHCS Research Institute Inc
Orlando,  Florida,  32806
United States
 

Dr Winkler Weinberg
Roswell,  Georgia,  30076
United States
 

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

Univ of Texas Southwestern Med Ctr of Dallas
Dallas,  Texas,  75235
United States
 

Texas Tech Health Sciences Ctr
El Paso,  Texas,  79905
United States
 

Grady Memorial Hosp / Hughs Spalding Med Ctr
Atlanta,  Georgia,  30335
United States
 

Univ TX San Antonio Health Science Ctr
San Antonio,  Texas,  78284
United States
 

Houston Clinical Research Network
Houston,  Texas,  77266
United States
 

Research Med Ctr
Kansas City,  Missouri,  64132
United States
 

Long Island Jewish Med Ctr
New Hyde Park,  New York,  11042
United States
 

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

Baylor College of Medicine
Houston,  Texas,  77005
United States
 

Dr Scott Lea
Waco,  Texas,  76708
United States
 

Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland,  Ohio,  44106
United States
 

Johns Hopkins School of Medicine
Baltimore,  Maryland,  21205
United States
 

Central Texas Med Foundation
Austin,  Texas,  78751
United States
 

CRI of New England
Brookline,  Massachusetts,  02445
United States
 


Additional Information:
Study ID Numbers:
  048A;  087023-999
Study Start Date: 
Record last reviewed: January 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002032

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

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

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

4. The Safety and Effectiveness of Rifabutin, Combined with Clarithromycin or Azithromycin, in HIV-Infected Patients

5. The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium avium Complex (MAC) Infection in HIV-Infected Patients

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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

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