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

Launched by LYPHOMED · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.