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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Trimetrexate glucuronate (Drug); Leucovorin calcium (Drug)

Phase: N/A

Status: Completed

Sponsored by: U.S. Bioscience

Official(s) and/or principal investigator(s):
Feinberg J, Study Chair

Summary

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).

Clinical Details

Official title: A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia

Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

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

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

United States Bioscience Inc, West Conshohocken, Pennsylvania 19428, United States
Additional Information

Related 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)


Last updated: June 23, 2005

Page last updated: August 23, 2015

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