A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections
Intervention: Pentamidine isethionate (Drug)
Phase: N/A
Status: Completed
Sponsored by: LyphoMed
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.
Clinical Details
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 design: Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
LyphoMed Inc, Rosemont, Illinois 60018, United States
Additional Information
Related 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)
Last updated: June 23, 2005
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