A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.

Completed · Not applicable

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

To provide trimetrexate glucuronate to immunosuppressed patients with Pneumocystis carinii pneumonia (PCP) for whom this investigational compound could provide significant medical benefit.

Key facts

Study ID

NCT00002102

Run by

U.S. Bioscience

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Antiretroviral therapy (at the discretion of the treating physician and/or medical monitor).
• Patients must have:
• Presumptive or definitive diagnosis of Pneumocystis carinii pneumonia (PCP).
• HIV positivity or be otherwise immunosuppressed.
• Demonstrated intolerance and/or resistance to trimethoprim/sulfamethoxazole during the course of therapy for the current episode and not candidates for parenteral pentamidine, OR a documented history of such intolerance during a prior episode.
• Consent of parent or guardian if less than 18 years of age.
• NOTE:
• In general, patients who meet the eligibility criteria for other U.S. Bioscience-sponsored clinical trials for trimetrexate would not be eligible for this Compassionate Use protocol.

You may not qualify if…

• Patients with the following prior conditions are excluded:
• History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions to trimetrexate.

Where it is running

• United States Bioscience Inc — West Conshohocken, Pennsylvania, United States

Full record on ClinicalTrials.gov

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