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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 - Article


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Sulfamethoxazole and Trimethoprim

Bactrim; Bactrim DS; Bethaprim; Co-trimoxazole; Cotrim; Cotrim DS; Septra; Septra DS; Sulfatrim 




Clinical Trial: 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.

Sponsored by: LyphoMed
Information provided by: AIDS Clinical Trials Information Service

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 Treatment or Intervention
Pneumonia, Pneumocystis carinii
HIV Infections
 Drug: Pentamidine isethionate

MedlinePlus related topics:  AIDS;   Fungal Infections;   Pneumocystis Carinii Infections;   Pneumonia;   Respiratory Diseases

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

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:

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.

Location Information


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

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
Record last reviewed:  August 1989
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002056
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 2, 2009



Page Updated: October 3, 2005
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