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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Azithromycin as Prophylaxis Against the Development of Mycobacterium Avium Complex Disease in HIV-Infected People

Conditions
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Mycobacterium Avium-Intracellulare Infection, HIV Infections

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Azithromycin