A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
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Purpose
To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia (PCP) in AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Leucovorin calcium |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Evaluation of Escalating Doses of Intravenous Trimetrexate as Therapy for Previously Untreated Pneumocystis Carinii Pneumonia in AIDS Patients With Subsequent Comparison of Intravenous and Oral Pharmacokinetics |
| Estimated Enrollment: | 50 |
| Study Completion Date: | April 1989 |
TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP.
Increasing doses of TMTX are used in combination with LCV as initial treatment for PCP in 50 AIDS patients. Doses are increased for 21 days on a once daily and then a twice daily basis. Dose escalations occur in subsequent groups of patients.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patient must:
- Have Pneumocystis carinii pneumonia (PCP) that has not been treated for current episode. PCP must be documented by observation of > 1 cluster of organisms in sputum, bronchial secretion, or lung tissue.
- Have clinical symptoms of respiratory disease or radiologic abnormalities.
Exclusion Criteria
- Patient cannot have significant emotional disorder.
Concurrent Medication: Excluded:
- Drugs likely to be bone marrow toxic.
- Investigational drugs.
Prior Medication: Excluded:
- Three patients in each group cannot have had zidovudine (AZT) for at least 2 months prior to administration of trimetrexate.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000998 History of Changes |
| Other Study ID Numbers: | ACTG 018, 10994 |
| Study First Received: | November 2, 1999 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Trimetrexate AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Injections, Intravenous Leucovorin Dose-Response Relationship, Drug |
Drug Therapy, Combination Folic Acid Antagonists Administration, Oral Acquired Immunodeficiency Syndrome Antineoplastic Agents |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Antineoplastic Agents Trimetrexate Folic Acid Antagonists Leucovorin Levoleucovorin Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins |
ClinicalTrials.gov processed this record on June 17, 2013