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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002030
• Other study ID #: 022E
• Secondary ID: 87-72B88-21
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of aerosol pentamidine when used as a prophylactic agent in patients who have had at least two or more episodes of AIDS-associated Pneumocystis carinii pneumonia (PCP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Pneumonia
• Pneumonia, Pneumocystis
• Pneumonia, Pneumocystis Carinii

Intervention

Drug:
• Pentamidine isethionate

Locations

Country	Name	City	State
United States	Fisons Corp	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fisons

Country where clinical trial is conducted

United States,