A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP

• Status: Completed
• Trial end date: 1989-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Calcium; Leucovorin; Levoleucovorin; Trimetrexate

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.