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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000998
Other study ID # ACTG 018
Secondary ID 10994
Status Completed
Phase Phase 1
First received
Last updated
Est. completion date April 1989

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 1989
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Drug:
Trimetrexate glucuronate

Leucovorin calcium


Locations

Country Name City State
United States Los Angeles County - USC Med Ctr Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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