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:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT00000666
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Required:
* Prophylactic treatment for Pneumocystis carinii pneumonia with aerosolized pentamidine, dapsone, or trimethoprim / sulfamethoxazole.
Allowed:
* Most medications not specifically excluded.
Prior Medication:
Allowed:
* Antivirals.
* Antiretrovirals.
Patients:
* Must be HIV positive or have an AIDS-defining illness OR be at known risk for HIV infection and have a CD4 cell count \< 200/mm3 and no other known immunosuppressive disease.
* Must have positive titer for Toxoplasma gondii.
* Must be or become a patient of a CPCRA physician.
* May participate in other clinical trials as long as there is no potential activity against Toxoplasma gondii or cross-toxicity among study drugs.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* History of ocular, pulmonary, or central nervous system (CNS) toxicity.
* CNS lesions.
* Neurologic deficits except peripheral neuropathy.
* Mild, moderate, severe, or end-stage AIDS dementia complex. Grade 3 or higher nausea and/or vomiting.
* Sensitivity to pyrimethamine.
Concurrent Medication:
Excluded:
* On-going therapy with clindamycin, fansidar, methotrexate, trimetrexate, spiramycin, azithromycin, clarithromycin, 566C80, and/or sulfa agents other than anti-PCP agents.
Patients with the following are excluded:
* History of ocular, pulmonary, or central nervous system (CNS) toxicity.
* CNS lesions or history of CNS lesions.
* Neurologic deficits except peripheral neuropathy.
* Mild, moderate, severe, or end-stage AIDS dementia complex. Grade 3 or higher nausea and/or vomiting.
* Sensitivity to pyrimethamine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00000666
Study Brief:
Protocol Section:
NCT00000666