A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00000998

First received: November 2, 1999

Last updated: December 17, 2012

Last verified: December 2012

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Pneumonia

Drug Information available for: Leucovorin calcium Trimetrexate glucuronate

Genetic and Rare Diseases Information Center resources: Pneumocystosis

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):


Estimated Enrollment:	50
Study Completion Date:	April 1989

Detailed Description:

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 (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000998

Locations


United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Study Chair:	Masur H

More Information

Publications:

Sattler FR, Allegra CJ, Verdegem TD, Akil B, Tuazon CU, Hughlett C, Ogata-Arakaki D, Feinberg J, Shelhamer J, Lane HC, et al. Trimetrexate-leucovorin dosage evaluation study for treatment of Pneumocystis carinii pneumonia. J Infect Dis. 1990 Jan;161(1):91-6.


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 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

ClinicalTrials.gov processed this record on September 28, 2016

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