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

NCT00000998 | Completed Phase 1

• 2 other identifiers: ACTG 01810994
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

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

Interventions

Trimetrexate glucuronate DRUG

Leucovorin calcium DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• 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. doi: 10.1093/infdis/161.1.91.

  PMID: 2136905 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome

Interventions

trimetrexate glucuronate; Leucovorin

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Masur H

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: April 1, 1989
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)