Expired Study
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West Conshohocken, Pennsylvania 19428


Purpose:

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


Study summary:

Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate.


Criteria:

Inclusion Criteria 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. Exclusion Criteria 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.


NCT ID:

NCT00002102


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

West Conshohocken, Pennsylvania 19428
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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