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

Completed · Not applicable

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

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).

Key facts

Study ID

NCT00002434

Run by

U.S. Bioscience

Last updated by the study team

2005-06-24

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• United States Bioscience Inc — West Conshohocken, Pennsylvania, United States

Full record on ClinicalTrials.gov

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