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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002056
• Other study ID #: 023A
• Secondary ID: 87-001
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 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

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.

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 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 Design

Masking: Double-Blind, 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	LyphoMed Inc	Rosemont	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
LyphoMed

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)