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A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy Clinical research trials and A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy. A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy clinical trial. Participants oftentimes recieve the finest healthcare available for their A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy



A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy

For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections,Tuberculosis, Mycobacterium Infection
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To evaluate the efficacy and safety of azithromycin given chronically for the treatment of serious nontuberculous mycobacterial infection in patients failing or intolerant of other available therapy.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Other antimicrobial drugs as long as documented on Case Report Form. Patients must have: - Serious nontuberculous mycobacterial infection. - Approval of eligibility from Pfizer Clinical Monitor. Patients below the legal age of consent must have consent of parent or guardian. NOTE: - Pregnant women, women of childbearing potential, and children will not be specifically excluded from participation. However, patients and physicians should be aware that the safety of azithromycin during pregnancy and in long-term use in children and adults has not been established. The risks and benefits of azithromycin use in these patients will be considered in consultation with the physician and the Pfizer Clinical Monitor. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Disseminated Mycobacterium avium complex (MAC) who are eligible for treatment with azithromycin under protocol 066-162. - Known hypersensitivity or intolerance to macrolide antibiotics. Patients with the following prior conditions are excluded: History of hypersensitivity or intolerance to azithromycin.
Total Enrollment: 

Location and Contact Information:

Natl Cancer Institute / Metabolism Branch
Bethesda,  Maryland,  20892
United States
 

Pfizer Central Research
Groton,  Connecticut,  06340
United States
 


Additional Information:
Study ID Numbers:
  058D;  066-169
Study Start Date: 
Record last reviewed: July 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002085

Other Hiv Infections Studies:
1. A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS

2. A Study of Azithromycin in the Prevention of Mycobacterium avium Complex Disease (MAC) in HIV-Infected Patients

3. 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

4. Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients with Disseminated Mycobacterium Avium Complex Infection

5. 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)

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