An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

Launched by FISONS · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Zidovudine (AZT).
• • Standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study.
• Concurrent Treatment:
• Allowed:
• • Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study.
• • Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP).
• • Patients must be free of acute medical problems.
• Prior Medication:
• Allowed:
• • Zidovudine (AZT).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Requiring ongoing active therapy for an opportunistic infection at the time of study entry.
• • Toxoplasmosis.
• • Cryptococcus.
• • Pulmonary Kaposi's sarcoma (KS).
• • Asthma poorly controlled by medication.
• Concurrent Medication:
• Excluded:
• * Pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
• • Septra, Fansidar, Dapsone, or eflornithine).
• Concurrent Treatment:
• Excluded:
• • Transfusion dependency defined as \> 1 blood transfusion per month.
• Patients with the following are excluded:
• • Requiring ongoing active therapy for an opportunistic infection (O.I.) at the time of entry or having either Toxoplasmosis or cryptococcosis at entry.
• • Pulmonary Kaposi's sarcoma (KS).
• • Active substance abuse by patients who cannot comply with study procedures.
• • Unwilling to sign informed consent.
• • In the opinion of the investigator cannot cooperate with study procedure.
• • Asthma poorly controlled by medication.
• * Patients may not receive pentamidine by any other route than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
• • Septra, Fansidar, Dapsone, or eflornithine).
• Prior Medication:
• Excluded within 30 days of study entry:
• • Antiretroviral agents, excluding zidovudine (AZT).
• • Immunomodulating agents.
• • Corticosteroids.
• Prior Treatment:
• Excluded within 7 days of study entry:
• • Blood transfusion.
• * Excluded:
• • Requiring ongoing active treatments for an opportunistic infection at time of study entry.
• • Active substance abuse by patients who cannot comply with study procedures.