NCT00002103

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: U.S. Bioscience · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Pneumonia, Pneumocystis Carinii
• HIV Infections

Interventions

Type	Name	Description
DRUG	Trimetrexate glucuronate
DRUG	Leucovorin calcium

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States