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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00001994
Eligibility Criteria:
Inclusion Criteria
Patients must have the following:
* Presumptive diagnosis of AIDS.
* Cerebral toxoplasmosis.
* Expected survival of at least four weeks without therapy.
* Willing and able to give informed consent.
Prior Medication:
Allowed:
* Pyrimethamine-sulfonamide.
* Clindamycin-sulfonamide.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Significant emotional disorder or psychosis.
* Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
* Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
* Ensure Plus) or pulverized form through a nasogastric tube.
* Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Concurrent Medication:
Excluded:
* Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.
* First three weeks of treatment:
* Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg:
* ddI,ddC).
Patients with the following are excluded:
* Significant emotional disorder or psychosis.
* Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
* Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
* Ensure Plus) or pulverized form through a nasogastric tube.
* Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00001994
Study Brief:
Protocol Section:
NCT00001994