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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00002053 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP
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Scientific title:
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A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP |
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Date of first enrolment:
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January 1976 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002053 |
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Study type:
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Interventional |
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Study design:
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Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Pneumonia, Pneumocystis Carinii
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Intervention(s)
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Drug: Pentamidine isethionate
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Secondary ID(s)
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022B
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87-72
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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