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

Completed · Not applicable

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002056

Run by

LyphoMed

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• LyphoMed Inc — Rosemont, Illinois, United States

Full record on ClinicalTrials.gov

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