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.

First Received: November 2, 1999 Last Updated: September 24, 2008 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000998

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 I

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison
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: AIDS Calcium Pneumonia

Drug Information available for: Leucovorin Citrovorum factor Trimetrexate Trimetrexate glucuronate Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

Estimated Enrollment:

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
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

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

Additional Information:

Click here for more information about Trimetrexate glucuronate This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	ACTG 018
Study First Received:	November 2, 1999
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00000998 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Communicable Diseases
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

ClinicalTrials.gov processed this record on November 27, 2009