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

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

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Key information

Conditions

Pneumonia, Pneumocystis Carinii Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Lung Diseases, Fungal Mycoses Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

1 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United States Bioscience Inc

West Conshohocken, Pennsylvania, 19428, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trimetrexate glucuronate

Drug

leucovorin calcium

Drug

Sponsors and collaborators

Lead sponsor

U.S. Bioscience

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed