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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002102

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: January 1994

History of Changes

Purpose

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

Condition	Intervention
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Trimetrexate glucuronate Drug: Leucovorin calcium


Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Pneumonia

Drug Information available for: Leucovorin calcium Trimetrexate glucuronate

Genetic and Rare Diseases Information Center resources: Pneumocystosis

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed 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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002102

Locations


United States, Pennsylvania
United States Bioscience Inc
West Conshohocken, Pennsylvania, United States, 19428

Sponsors and Collaborators

U.S. Bioscience

More Information

Publications:

Feinberg J, McDermott C, Nutter J. Trimetrexate (TMTX) salvage therapy for PCP in AIDS patients with limited therapeutic options. Int Conf AIDS. 1992 Jul 19-24;8(2):B136 (abstract no PoB 3297)


ClinicalTrials.gov Identifier:	NCT00002102 History of Changes
Other Study ID Numbers:	132B TMTX C010
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:


Trimetrexate Pneumonia, Pneumocystis carinii Leucovorin Drug Therapy, Combination Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:


HIV Infections Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal	Mycoses Pneumocystis Infections Levoleucovorin Trimetrexate Antidotes Protective Agents Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Folic Acid Antagonists Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2016

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