A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
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ClinicalTrials.gov Identifier: NCT00002434 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumonia, Pneumocystis Carinii HIV Infections | Drug: Trimetrexate glucuronate Drug: Leucovorin calcium | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia |

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Ages Eligible for Study: | 2 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002434
United States, Pennsylvania | |
United States Bioscience Inc | |
West Conshohocken, Pennsylvania, United States, 19428 |
Study Chair: | Feinberg J |
Publications:
ClinicalTrials.gov Identifier: | NCT00002434 History of Changes |
Other Study ID Numbers: |
132A TMTX 0014 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | January 1994 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Trimetrexate Pneumonia, Pneumocystis carinii Leucovorin Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal |
Mycoses Pneumocystis Infections Levoleucovorin Trimetrexate Antidotes Protective Agents Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Folic Acid Antagonists Enzyme Inhibitors |