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A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
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: NCT00002434
  Purpose

To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in 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

Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study
Official Title: A Study of Trimetrexate Glucuronate (Neutrexin) 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. Patients are followed for 1 month.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Myelosuppressive or nephrotoxic agents at the discretion of the treating physician.

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.

NOTE:

  • Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk.

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: NCT00002434

Locations
United States, Pennsylvania
United States Bioscience Inc
West Conshohocken, Pennsylvania, United States, 19428
Sponsors and Collaborators
U.S. Bioscience
Investigators
Study Chair: Feinberg J
  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: 132A, TMTX 0014
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002434     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