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 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT01562132
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to give informed consent
* Age \> 18 years
* HIV infection as confirmed by HIV-antibody test as per Kenyan guidelines
* CD4+ T-cell count ≤100 cells/µl
* Serum CrAg titer≥1:2
* Able to travel to district hubs (Sindo District Hospital, Lumumba Health Centre) for regular study visits
Exclusion Criteria:
* clinical meningitis:
* clinical sepsis:
* hemiparesis, aphasia, visual field deficit or other finding on neurological examination localizable to the central nervous system
* a history of culture proven or suspected (cryptococcal antigen present) cryptococcal meningitis
* a history of stroke or other infection of the central nervous system
* a seizure within the last 2 months
* currently taking or ever taken antiretroviral therapy
* currently taking anti-tuberculous therapy
* currently or recently (\<2 months) prescribed fluconazole, itraconazole, clotrimazole troches, amphotericin or other oral anti-fungal medications
* pregnant or breast-feeding
* alanine aminotransferase concentration more than 3 times the upper limit of normal
* neutrophil count \<1000x103 cells/mL
* hemoglobin \<8g/dL
* platelet count \<100,000x 103 platelets/mL
* creatinine clearance ≤50 ml/min
* individuals with active heavy alcohol use or active recreational drug use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01562132
Study Brief:
Protocol Section:
NCT01562132