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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT01929759
Eligibility Criteria:
Inclusion Criteria:
* Chronic HIV-infected individuals on suppressive regimen with EFV/FTC/TDF, for at least 6 months
* Undetectable HIV-1 RNA virus load for at least 6 months
* No co-infections with active hepatitis B and C
* Presence of at least moderate symptoms on 2 out of 3 subcores on the DASS
* No known active HIV-related and non-HIV related CNS infections
* Estimated glomerular filtration rate (EGFR) \>60 ml/min
* Consent to switching to EVG/COBI/FTC/TDF
* Ages 18 - 65
Exclusion Criteria:
* History of CNS opportunistic infections or active CNS infections
* History of severe psychiatric disorder (excluding depression and anxiety)
* History of chronic neurological disorders, such as epilepsy or multiple sclerosis
* History of or current significant substance abuse or dependence and/or heavy alcohol use (\>12 oz/wk)
* Any women who may be pregnant (positive urine pregnancy test or unprotected sex in 2 weeks prior to scan) or known to be pregnant
* Contraindications to undergoing fMRI, including metallic implants, claustrophobia, and medical conditions or medications that significantly affect cerebral blood flow or function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01929759
Study Brief:
Protocol Section:
NCT01929759