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 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT04266002
Eligibility Criteria:
Inclusion Criteria:
1. Subject (male or female) with HIV-1 infection
2. Subject is ≥ 18 years of age
3. Subject with a plasma viral load (HIV-1 RNA) undetectable for at least one year or with minimal replication \<500 copies/ml for at least one year at the inclusion date
4. Patient with HIV-associated neurocognitive disorders : at least two ability domains, documented by performance of at least 1.0 standard deviation below the mean for age-education appropriate norms on standardized neuropsychological tests
5. Patient is willing and able to understand and provide written informed consent prior to participation in this study
Exclusion Criteria:
1. Subject with HIV-2 infection
2. Subject with plasma viral load (HIV-1 RNA)\> 500 copies/ml in the past year
3. Subject with acquired impairment in cognitive functioning involving only one ability domain, or involving at least two ability domains but with performance better than 1.0 standard deviation below the mean (no evidence of potential cognitive impairment)
4. Subject unable, according to the investigator, to meet the study requirements, including patients unable to perform cognitive tests
5. Subject with acute intercurrent disease
6. Patient with positive serology for HCV or HBsAg positive
7. Subject with cognitive impairment related to another cause than HIV: other CNS infection, CNS neoplasm, cerebrovascular disease, preexisting neurologic disease or metabolic disorders, severe substance abuse, or systemic disease.
8. Subject with a brain MRI or CSF analysis results that suggest another pathology than HIV associated neurocognitive disorder
9. Subject requires treatment with immunomodulating agents (or may require such treatment during the two years monitoring) such as systemic corticosteroïds, interferons, interleukins, growth factor GM- CSF, or other targeted therapy that may interfere with macrophage markers of the study
10. Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents
11. Subject at which the initial lumbar punction can't be achieved
12. Subject ≥65 years at the inclusion date, age with high risk of atherosclerotic disease
13. Subject with significant depression : with a score ≥29 (or score
≥20 without questions 15 to 21) at Beck Depression Inventory II (1996 version), the neuropsychologist doesn't conduct the battery of cognitive tests
14. Subject under curatorship or guardianship
15. Subject at which the initial cerebral MRI can't be achieved
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04266002
Study Brief:
Protocol Section:
NCT04266002