A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
Pneumonia, Pneumocystis Carinii, HIV Infections
About this trial
This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Patients must have the following: Diagnosis of PCP. Fit the CDC definition of AIDS. Be receiving intravenous or oral trimethoprim / sulfamethoxazole (Bactrim, Septra) in doses of = or > 15mg/kg/day of the trimethoprim component. Be receiving = or < 48 hours of trimethoprim / sulfamethoxazole (TMP / SMX) prior to randomization. Must sign informed consent in accordance with FDA guidelines. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Cannot take oral medications. Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. Concurrent Medication: Excluded: Continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. Patients with the following are excluded: Cannot take oral medications. Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. Prior Medication: Excluded: > 48 hours of trimethoprim / sulfamethoxazole prior to randomization.
Sites / Locations
- San Francisco Gen Hosp