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:
NCT01966094
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed HIV infection (HAART naïve), subjects 18 to 59 years of age
2. Negative serum cryptococcal antigen if CD4+ T-cell count \<100 cells/microliter, normal serum thyroid stimulating hormone level, negative serum rapid plasma reagin (RPR) (Can have positive RPR ≤1:4 if treated for syphilis by CDC guidelines at least 6 months prior to enrollment, had no signs/symptoms of neurosyphilis, and RPR titer decreased at least 4-fold by 6 months after treatment).
Exclusion Criteria:
1. Ongoing heavy alcohol use (more than 2 drinks per day) or ongoing illicit drug use
2. Schizophrenia or other psychotic disorder, bipolar disorder, or uncontrolled depression as reported by the subject or medical provider.
3 Neoplasm of the CNS OR history of traumatic brain injury with loss of consciousness \> 30 minutes OR CNS infection in the last 6 months.
4\. Pregnancy or incarceration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT01966094
Study Brief:
Protocol Section:
NCT01966094