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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
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: LyphoMed
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002056
  Purpose

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.


Condition Intervention
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Pentamidine isethionate

Study Type: Interventional
Study Design: Treatment, Double-Blind
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

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002056

Locations
United States, Illinois
LyphoMed Inc
Rosemont, Illinois, United States, 60018
Sponsors and Collaborators
LyphoMed
  More Information

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 ID Numbers: 023A, 87-001
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002056     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Trimethoprim-Sulfamethoxazole Combination
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Pentamidine
Injections, Intravenous
Administration, Oral
Aerosols
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Trypanocidal Agents
Anti-Infective Agents
Communicable Diseases
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Trimethoprim
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Trimethoprim-Sulfamethoxazole Combination
Renal Agents
Infection
Antimalarials
Pneumonia, Pneumocystis
Mycoses
Antiparasitic Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Antifungal Agents
Pentamidine
Retroviridae Infections
Lung Diseases, Fungal
RNA Virus Infections
Immune System Diseases
Sulfamethoxazole
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009