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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT06603727
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of an HIV infection
* Undetectable HIV load in the serum (\<50 copies/mL) over the last 6 months prior to study inclusion.
* Z-score ≤ -1.0 in at least one of the three following tests:
* Color Trail Test (CTT) Flexibility Index
* subtest Code of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
* subtest Digit Span of the WAIS-IV
* Z-score ≤ -1.0 in at least one of the following tests:
* Symbol Digits Modalities Test (SDMT)
* Brief Visuospatial Memory Test Revised (BVMT-R)
* CTT Flexibility Index
* Stroop Color-Word interference test
Exclusion Criteria:
* Clinically defined cause for cognitive deficits other than HIV
* Diagnosis of severe depression according to a cut-off score of ≥ 27 of the Center for epidemiological studies - depression questionnaire (CES-D; Metral et al., 2020; Radloff, 1977)
* Diagnosis of HIV-associated dementia according to the Frascati Critera (Antinori et al., 2007)
* Current psychotic symptoms according to the Mini-International Neuropsychiatric Interview (M.I.N.I. - L, Sheehan et al., 1998) subscale of psychotic symptoms
* Antidepressive, anxiolytic or cART medication that has been changed over the last month
* Thoracic pain and/or heart palpitations at rest, during or following a physical effort (based on self-report)
* For patients without known and clinically stable cardio-vascular disease: abnormal rest electrocardiogram readings suggestive of second degree type Mobitz or third degree atrioventricular blocking, pathological repolarization (T-wave inversion, ST elevation, abnormal QT lengthening in at least two corresponding leads), or typical features of channelopathies
* Premature termination of maximal effort test due to cardiac problems
* Falls in the past 12 weeks as evaluated in the enrolment interview (Hopkins Falls Grading Scale, Grade \>1)
* High risk of falling according a cutoff score \> 15 sec in the Four Square Step Test (Dite \& Temple, 2002)
* Incapacity to discriminate colors or insufficient visual acuity that cannot be corrected
* Incapacity or unwillingness to provide informed consent
* Insufficient knowledge of French to understand and follow instructions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06603727
Study Brief:
Protocol Section:
NCT06603727