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

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ClinicalTrials.gov Identifier: NCT00002102
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

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

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumocystis Carinii HIV Infections Drug: Trimetrexate glucuronate Drug: Leucovorin calcium Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Pneumonia
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002102


Locations
United States, Pennsylvania
United States Bioscience Inc
West Conshohocken, Pennsylvania, United States, 19428
Sponsors and Collaborators
U.S. Bioscience
More Information
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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
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1994

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