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

U.S. Bioscience

Status: Completed

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Treatments: Drug: Leucovorin calcium; Drug: Trimetrexate glucuronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002102

TMTX C010

132B

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 1+ day old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.