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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.
Study NCT00002102   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002102 on ClinicalTrials.gov Archive Site
 
 
 
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.

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

Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate.

 
Interventional
Treatment, Open Label
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
  • Drug: Trimetrexate glucuronate
  • Drug: Leucovorin calcium
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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.

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002102
 
132B, TMTX C010
U.S. Bioscience
 
 
NIH AIDS Clinical Trials Information Service
January 1994

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP