Pneumonia, Pneumocystis Carinii, HIV Infections
Conditions
Keywords
Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome
Brief summary
The primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.
Interventions
Sponsors
Lederle Laboratories
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed