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

June 23, 2005 updated by: Fisons
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 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
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess - West Campus

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine (AZT).

Patients must have:

  • AIDS.
  • 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:

Excluded:

  • 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.

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: Double

Collaborators and Investigators

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

Sponsor

Fisons

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022D
  • 88-7

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.

Clinical Trials on HIV Infections

Clinical Trials on Pentamidine isethionate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe