A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP

Study Overview
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Brief Summary
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To evaluate and compare the safety, tolerability, and effectiveness of long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had multiple episodes of AIDS associated Pneumocystis carinii pneumonia (PCP).

Official Title
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A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP

Conditions
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Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
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* Drug: Pentamidine isethionate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Patients must have: AIDS. Recovered from their most recent episode of Pneumocystis carinii pneumonia (PCP). Patients must be at least 2 weeks status post therapy for acute PCP. Adequate pulmonary function (vital capacity = or > 65 percent of predicted; forced expiratory volume, 1 s = or > 55 percent of total FEV; and corrected pulmonary diffusion capacity > 50 percent of predicted). Patients must be free of acute medical problems. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: AIDS-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis. Pulmonary Kaposi's sarcoma. Asthma poorly controlled by medication. Receiving active therapy for tuberculosis. Concurrent Medication: Excluded: Active therapy for tuberculosis. Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection at time of study entry. AIDS-defining opportunistic infection prior to study entry such as toxoplasmosis and cryptococcosis. Pulmonary Kaposi's sarcoma. Unwilling to sign informed consent. Asthma poorly controlled by medication. Unwilling to cooperate with study procedures. Receiving active therapy for tuberculosis. Prior Medication: Excluded within 30 days of study entry: Antiretrovirals (other than zidovudine (AZT)). Immunomodulating agents. Corticosteroids. Prior Treatment: Excluded within 7 days of study entry: Transfusion. Patient cannot be transfusion dependent (requiring blood transfusion more than once per month). Active substance abuse.

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: Pentamidine isethionate|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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AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Dose-Response Relationship, Drug, Aerosols, Acquired Immunodeficiency Syndrome