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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 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 Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their 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 condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > 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
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. Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
2. Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
3. A Study of Letrazuril in the Treatment of AIDS-Related Diarrhea
4. Evaluation of the Interaction Between Acetaminophen and Zidovudine
5. The Effectiveness of Human Antibodies in Influencing an AIDS-Like Disease in Monkeys
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Other HIV Infections Clinical Trials
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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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