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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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Completion Date
April 1, 1989
Last Updated
November 4, 2021
50
Estimated participants
Trimetrexate glucuronate
DRUG
Leucovorin calcium
DRUG
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NCT06694805
NCT04142047
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07428330