Trial record 6 of 70 for:
A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1994
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).
Pneumonia, Pneumocystis Carinii
Drug: Trimetrexate glucuronate
Drug: Leucovorin calcium
||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
||A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia
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.
|Ages Eligible for Study:
||2 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002434
|United States Bioscience Inc
|West Conshohocken, Pennsylvania, United States, 19428 |
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)
History of Changes
|Other Study ID Numbers:
||132A, TMTX 0014
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Pneumonia, Pneumocystis carinii
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Vitamin B Complex
Physiological Effects of Drugs