A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS

June 23, 2005 updated by: LyphoMed
This is a randomized double-blinded controlled study comparing aerosolized pentamidine with trimethoprim plus sulfamethoxazole (TMP / PurposeX). The latter drug will be administered intravenously for at least 5 days, then changed to oral administration if warranted by the patient's clinical condition.

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
    • Illinois
      • Rosemont, Illinois, United States, 60018
        • LyphoMed Inc

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 as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.

Pneumocystis carinii pneumonia (PCP) in an adult who is HIV positive by ELISA, HIV culture, or p24 antigenemia, or is a member of a risk group for HIV infection (homosexual or bisexual men, intravenous drug abusers, recipients of HIV infected blood products, and the sexual partners of the foregoing groups).

  • The patient must have a resting Alveolar - arterial oxygen (A-a) DO2 less than 30 mmHg on room air at all ACTG sites, except San Francisco General Hospital. Other sites will enter patients up to a resting (A-a) DO2 = or < 55 mmHg on room air.

Prior Medication:

Allowed:

  • Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Dyspnea.
  • Cough.
  • Bronchospasm.
  • History of a major adverse reaction to pentamidine or sulfonamide containing preparations.

Patients with the following will be excluded:

  • Inability to cooperate with aerosol administration because of dyspnea, cough, bronchospasm, or other reasons.
  • History of a major adverse reaction to pentamidine or sulfonamide containing preparations.
  • In the opinion of the investigator, the patient would not complete therapy or follow-up for social reasons.

Prior Medication:

Excluded within 14 days of study entry:

  • Systemic steroids above adrenal replacement doses.
  • Excluded within 6 weeks of study entry:
  • Other antiprotozoal regimen for this episode such as trimethoprim / sulfamethoxazole (TMP / PurposeX).
  • Pyrimethamine.
  • Fansidar.
  • Pentamidine.
  • Eflornithine (DFMO).
  • Dapsone, whether therapeutic or prophylactic, or any of these agents.

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

LyphoMed

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

  • Montgomery AB, Edison RE, Sattler F, Hopewell P, Mason G, Feigal DW. Aerosolized pentamidine vs. trimethoprim/sulfamethoxazole for acute Pneumcoystis carinii pneumonia (PCP): a randomized double blind trial. Int Conf AIDS. 1990 Jun 20-23;6(1):220 (abstract no ThB395)

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

August 1, 1989

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 023A
  • 87-001

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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