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A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia

This study has been completed.

Sponsored by: U.S. Bioscience
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002103
  Purpose

To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in European patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).


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

MedlinePlus related topics:   AIDS    Pneumonia   

Drug Information available for:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Calcium gluconate    Trimetrexate    Trimetrexate glucuronate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Safety Study
Official Title:   A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia

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. Patients are followed for 1 month.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
  • Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, OR a documented history of such intolerance during a prior episode.
  • Consent of parent or guardian if less than 18 years of age.

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 due to trimetrexate glucuronate.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002103

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:   132C, TMTX C502
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002103
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:
Sexually Transmitted Diseases, Viral
Clotrimazole
Pneumocystosis
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Leucovorin
Immunologic Deficiency Syndromes
Folic Acid
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Retroviridae Infections
Trimetrexate
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Antimetabolites, Antineoplastic
Slow Virus Diseases
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Infection
Pharmacologic Actions
Therapeutic Uses
Vitamins
Antifungal Agents
Lentivirus Infections
Micronutrients

ClinicalTrials.gov processed this record on December 03, 2008




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