Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT00002002
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002002
Study Brief:
Protocol Section:
NCT00002002