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.
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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:
- 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.
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)
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
Resources
- Antibiotic Medications (Cleveland Clinic)
- Bactrim (Drug Digest)

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