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Home > "A" Clinical Trials Conditions > A Study of Azithromycin in the Prevention of Mycobacterium avium Complex Disease (MAC) in HIV-Infected Patients  A Study of Azithromycin in the Prevention of Mycobacterium avium Complex Disease (MAC) in HIV-Infected Patients
A Study of Azithromycin in the Prevention of Mycobacterium avium Complex Disease (MAC) in HIV-Infected Patients
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To evaluate the efficacy and safety of azithromycin administered once a week in the prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised HIV-infected patients with a CD4 count < 100 cells/mm3.
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: Required: - Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or without dihydrofolate reductase inhibitors, pentamidine). Allowed: - Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including azoles). Patients must have: - HIV infection. - CD4 count < 100 cells/mm3. - No MAC positive blood cultures within 1 month prior to study entry. - No symptoms suggestive of disseminated MAC infection (including unexplained diarrhea, fever, and night sweats) within 1 month of study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Positive PPD within 3 months prior to study entry (negative PPD defined as < 5 mm induration). - Chest x-ray suggestive of any active disease, in particular tuberculosis. - Known hypersensitivity to macrolide antibiotics. - Any other acute clinical condition likely to interfere with completion of the protocol. - Inability to care for self without considerable assistance and medical care. Concurrent Medication: Excluded: - Other investigational new drugs (except for foscarnet or ddC) unless prior agreement has been reached between the investigator and the Pfizer project physician. - Concomitant putative immunostimulants. Patients with the following prior conditions are excluded: History of MAC or Mycobacterium tuberculosis (MTb) infection. Prior Medication: Excluded within the past 4 weeks: - Any putative anti-MAC therapies including rifampin, rifabutin, clofazimine, ethambutol, cycloserine, ethionamide, amikacin, and ciprofloxacin or other quinolones thought to be active against MAC.
Total Enrollment:
Location and Contact Information:
Womack Army Med Ctr / Med Clinic
Fort Bragg, North Carolina, 283075000
United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300
United States
San Diego Naval Hosp
San Diego, California, 921345000
United States
Additional Information:
Study ID Numbers: 058I; 066-155
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002309
Other Hiv Infections Studies:
1. A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
2. A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS
3. The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients
4. 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
5. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
Related Studies:
Other HIV Infections Clinical Trials
Other Texas Clinical Trials
Other Lackland Air Force Base Clinical Trials
A Study of Azithromycin in the Prevention of Mycobacterium avium Complex Disease (MAC) in HIV-Infected Patients
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