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| Sponsored by: |
U.S. Bioscience |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002434 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Leucovorin calcium |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia |
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
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.
Contacts and Locations
More Information
| Study ID Numbers: | 132A, TMTX 0014 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002434 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Trimetrexate Pneumonia, Pneumocystis carinii Leucovorin Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
|
Antimetabolites Sexually Transmitted Diseases, Viral Folate Leucovorin Vitamin B9 Pneumonia, Pneumocystis Mycoses Respiratory Tract Infections Respiratory Tract Diseases Vitamins Antifungal Agents Micronutrients Retroviridae Infections Trimetrexate Lung Diseases, Fungal |
Vitamin B Complex Pneumocystosis Acquired Immunodeficiency Syndrome Trace Elements Folinic Acid Folic Acid Antagonists Immunologic Deficiency Syndromes Folic Acid Virus Diseases Calcium, Dietary Pneumocystis Infections HIV Infections Lung Diseases Sexually Transmitted Diseases Pneumonia |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Antimetabolites, Antineoplastic Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Infection Pneumonia, Pneumocystis Mycoses Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses |
Antifungal Agents Vitamins Micronutrients Retroviridae Infections Trimetrexate Lung Diseases, Fungal RNA Virus Infections Vitamin B Complex Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Immunologic Deficiency Syndromes |