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

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pentamidine isethionate
Sponsored by
LyphoMed
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Injections, Intravenous, Administration, Oral, Aerosols, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LyphoMed Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
LyphoMed
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1. Study Identification

Unique Protocol Identification Number
NCT00002056
Brief Title
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
LyphoMed

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Injections, Intravenous, Administration, Oral, Aerosols, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pentamidine isethionate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
LyphoMed Inc
City
Rosemont
State/Province
Illinois
ZIP/Postal Code
60018
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS

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