Expired Study
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Rochester, New York 14603


Purpose:

To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of 1 of 3 doses of aerosol pentamidine 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). 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). - Asthma requiring medication. - 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 (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). - Unwilling to sign informed consent. - Cannot cooperate with study procedures. - Asthma requiring medication. Prior Medication: Excluded within 30 days of study entry: - Antiretrovirals other than zidovudine (AZT). - Immunomodulating agents. - Corticosteroids. Patients must: - Have AIDS and recovered from their first episode of cytologically or histologically proven 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 any federally licensed ELISA test kit, or confirmed Western blot test. - Have 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:

NCT00002291


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 22, 2017

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