Expired Study
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Rochester, New York 14603


Purpose:

To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of aerosol pentamidine versus placebo when used as a prophylactic agent in patients who have recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT). If AZT is started during the study, patients must have received = or > 15 days of aerosol pentamidine before beginning AZT. Prior Medication: Allowed: - Zidovudine (AZT). If AZT began prior to study entry, patients must have received = or > 15 days of AZT before beginning aerosol pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry: - Toxoplasmosis. - Cryptococcosis. - Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry. - Pulmonary Kaposi's sarcoma (KS). - Uncontrolled asthma. - Active therapy for tuberculosis. Patients with the following are excluded: - Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry: - Toxoplasmosis. - Cryptococcosis. - Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry. - Pulmonary Kaposi's sarcoma (KS). - Uncontrolled asthma. Prior Medication: Excluded within 30 days of study entry: - Antiretroviral agents other than zidovudine (AZT). - Immunomodulating agents. - Corticosteroids. Active therapy for tuberculosis. Patients must: - Have AIDS and recovered from their first episode of Pneumocystis carinii pneumonia (PCP). - Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP. - Have positive antibody to HIV by a Government-approved ELISA test kit, or confirmed Western blot test. - Adequate pulmonary function (vital capacity = or > 80 percent of predicted; forced expiratory volume (FEV), 1 s = or > 65 percent of total FEV; and corrected pulmonary diffusion capacity > 60 percent of predicted). - Free of acute medical problems. Active substance abuse.


NCT ID:

NCT00002053


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Rochester, New York 14603
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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