drugset / Trial / NCT00002120

Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia

NCT00002120

Phase 1 Completed 20 enrolled U.S. Bioscience Jacobus Pharmaceutical · collab
Double-blindTreatment

Summary

To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS and moderately severe PCP.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapsone Small molecule
Subject Leucovorin Small molecule
Subject Sulfamethoxazole Small molecule
Subject Trimethoprim Small molecule
Subject Trimetrexate Unknown