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

June 23, 2005 updated by: Fisons
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14603
        • Fisons Corp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisons

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 1989

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022E
  • 87-72B
  • 88-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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