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A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: U.S. Bioscience
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002102
  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: Treatment, Open Label
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:


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

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
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)

Study ID Numbers: 132B, TMTX C010
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002102     History of Changes
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

Study placed in the following topic categories:
Antimetabolites
Sexually Transmitted Diseases, Viral
Folate
Leucovorin
Vitamin B9
Pneumonia, Pneumocystis
Mycoses
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamins
Antifungal Agents
Micronutrients
Retroviridae Infections
Trimetrexate
Lung Diseases, Fungal
Vitamin B Complex
Pneumocystosis
Acquired Immunodeficiency Syndrome
Trace Elements
Folinic Acid
Folic Acid Antagonists
Immunologic Deficiency Syndromes
Folic Acid
Virus Diseases
Calcium, Dietary
Pneumocystis Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Pneumonia

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Antimetabolites, Antineoplastic
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leucovorin
Infection
Pneumonia, Pneumocystis
Mycoses
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Antifungal Agents
Vitamins
Micronutrients
Retroviridae Infections
Trimetrexate
Lung Diseases, Fungal
RNA Virus Infections
Vitamin B Complex
Immune System Diseases
Growth Substances
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on July 02, 2009