A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.
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ClinicalTrials.gov Identifier: NCT00002102 |
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 Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia. |

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antiretroviral therapy (at the discretion of the treating physician and/or medical monitor).
Patients must have:
- Presumptive or definitive diagnosis of Pneumocystis carinii pneumonia (PCP).
- HIV positivity or be otherwise immunosuppressed.
- Demonstrated intolerance and/or resistance to trimethoprim/sulfamethoxazole during the course of therapy for the current episode and not candidates for parenteral pentamidine, OR a documented history of such intolerance during a prior episode.
- Consent of parent or guardian if less than 18 years of age.
NOTE:
- In general, patients who meet the eligibility criteria for other U.S. Bioscience-sponsored clinical trials for trimetrexate would not be eligible for this Compassionate Use protocol.
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 to trimetrexate.

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): NCT00002102
United States, Pennsylvania | |
United States Bioscience Inc | |
West Conshohocken, Pennsylvania, United States, 19428 |
Publications:
ClinicalTrials.gov Identifier: | NCT00002102 History of Changes |
Other Study ID Numbers: |
132B TMTX C010 |
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 |