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Sponsored by: |
U.S. Bioscience |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002102 |
To provide trimetrexate glucuronate to immunosuppressed patients with Pneumocystis carinii pneumonia (PCP) for whom this investigational compound could provide significant medical benefit.
Condition | Intervention |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Leucovorin calcium |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia. |
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 to trimetrexate.
Study ID Numbers: | 132B, TMTX C010 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002102 |
Health Authority: | United States: Food and Drug Administration |
Trimetrexate Pneumonia, Pneumocystis carinii Leucovorin Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases, Viral Clotrimazole Pneumocystosis Miconazole Acquired Immunodeficiency Syndrome Tioconazole Leucovorin Immunologic Deficiency Syndromes Folic Acid Virus Diseases Calcium, Dietary Mycoses |
Pneumonia, Pneumocystis Pneumocystis Infections Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Lung Diseases Sexually Transmitted Diseases Retroviridae Infections Trimetrexate Pneumonia Lung Diseases, Fungal |
Antimetabolites Anti-Infective Agents RNA Virus Infections Antimetabolites, Antineoplastic Slow Virus Diseases Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists Infection Pharmacologic Actions Therapeutic Uses Vitamins Antifungal Agents Lentivirus Infections Micronutrients |