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Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS Clinical research trials and Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS. Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

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



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

For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients. Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
Details: Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown. Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended in patients with CD4 count <= 200 cells/mm3: - Antiretroviral therapy. - PCP prophylaxis. Allowed in all patients: - Isoniazid preventive therapy. Patients must have: - HIV infection. - Evidence of disseminated MAC infection. NOTE: - Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known hypersensitivity to the study drugs. - Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis. Concurrent Medication: Excluded: - Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen). - Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).
Total Enrollment: 400

Location and Contact Information:

Overall Study Official:
CohnD,  Study Chair, 

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

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

Richmond AIDS Consortium
Richmond,  Virginia,  23298
United States
 

Philadelphia FIGHT
Philadelphia,  Pennsylvania,  19107
United States
 

Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Denver CPCRA / Denver Public Hlth
Denver,  Colorado,  802044507
United States
 

Partners Research
Albuquerque,  New Mexico,  871315271
United States
 

AIDS Research Alliance - Chicago
Chicago,  Illinois,  60657
United States
 

Community Consortium of San Francisco
San Francisco,  California,  94110
United States
 

Baltimore Trials
Baltimore,  Maryland,  21201
United States
 

Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C.,  District of Columbia,  20422
United States
 

Comprehensive AIDS Alliance of Detroit
Detroit,  Michigan,  48201
United States
 

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans,  Louisiana,  70112
United States
 

Southern New Jersey AIDS Cln Trials / Dept of Med
Camden,  New Jersey,  08103
United States
 

Henry Ford Hosp
Detroit,  Michigan,  48202
United States
 

Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland,  Oregon,  972109951
United States
 


Additional Information:
Study ID Numbers:
  CPCRA 027; 
Study Start Date: 
Record last reviewed: August 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001047

Other Mycobacterium Avium-Intracellulare Infection Studies:
1. A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

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

3. An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium avium-intracellulare Complex Infection (MAC) in Patients with Acquired Immune Deficiency Syndrome (AIDS)

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

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

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

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