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The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Who Have Had PCP Before



The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Who Have Had PCP Before

For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): Fisons ,
Synopsis: 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).
Details:
Eligibility:
Study Type:  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Fisons Corp
Rochester,  New York,  14603
United States
 


Additional Information:
Study ID Numbers:  022A;  87-71
Study Start Date: 
Record last reviewed: October 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002291

Other Pneumonia, Pneumocystis Carinii Studies:
1. Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis carinii Pneumonia

2. A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides

3. Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis carinii Pneumonia Prophylaxis

4. A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)

5. A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients

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