Status:
COMPLETED
A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 TMT...
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 ...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1989
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00000998
End Date
April 1 1989
Last Update
November 4 2021
Active Locations (1)
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1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033