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

November 2, 1999
December 17, 2012
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Complete list of historical versions of study NCT00000998 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
  • Drug: Trimetrexate glucuronate
  • Drug: Leucovorin calcium
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 1989
Not Provided

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000998
ACTG 018, 10994
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Masur H
National Institute of Allergy and Infectious Diseases (NIAID)
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP