Search / Trial NCT00000998

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 27, 2024

Completed

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

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.

Trial Officials

Masur H

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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