NCT00002055CompletedNot Applicable
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
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fisons
- Locations
- 8
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •Zidovudine (AZT).
- •Patients must have:
- •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:
- •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.
Investigators
Study Sites (8)
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