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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS    Pneumonia   

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

U.S. FDA Resources

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

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

Estimated Enrollment:   50

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

Investigators
Study Chair:     Masur H    
  More Information


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

Publications:

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

Study placed in the following topic categories:
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Clotrimazole
Pneumocystosis
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Leucovorin
Immunologic Deficiency Syndromes
Folic Acid
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Infections
Respiratory Tract Diseases
HIV Infections
Lung Diseases
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Retroviridae Infections
Trimetrexate
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Antimetabolites, Antineoplastic
Slow Virus Diseases
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Infection
Pharmacologic Actions
Therapeutic Uses
Vitamins
Antifungal Agents
Lentivirus Infections
Micronutrients

ClinicalTrials.gov processed this record on December 03, 2008




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