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

NCT ID: NCT00002030

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief 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).

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Pentamidine isethionate

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisons

INDUSTRY

Sponsor Role: lead

Locations

Fisons Corp

Rochester, New York, United States

Countries

United States

Other Identifiers

87-72B

Identifier Type: -

Identifier Source: secondary_id

88-21

Identifier Type: -

Identifier Source: secondary_id

022E

Identifier Type: -

Identifier Source: org_study_id