A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
U.S. Bioscience
Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate.
Age
0–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
