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 - Full Text View

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