Prospective study in HIV-1 infected adult subjects with HIV-associated neurocognitive disorders despite effective antiretroviral therapy in plasma for more than one year, analyzing the evolution of cognitive disorders and markers of macrophagic inflammation in blood and cerebrospinal fluid, after a change in HIV treatment with an increased of the new scale CHARTER score ≥ 3 (total treatment score to be ≥ 9)
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject (male or female) with HIV-1 infection
✓. Subject is ≥ 18 years of age
✓. 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
✓. 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
✓. Patient is willing and able to understand and provide written informed consent prior to participation in this study
Exclusion criteria
✕. Subject with HIV-2 infection
✕. Subject with plasma viral load (HIV-1 RNA)\> 500 copies/ml in the past year
✕. 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)
✕. Subject unable, according to the investigator, to meet the study requirements, including patients unable to perform cognitive tests
✕. Subject with acute intercurrent disease
✕. Patient with positive serology for HCV or HBsAg positive
What they're measuring
1
Demonstrate a significant improvement in HIV associated neurocognitive disorders after ARV intensification with increased CNS Penetration Effectiveness scoring ≥+3 and total CPE score ≥9.
. 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.
✕. Subject with a brain MRI or CSF analysis results that suggest another pathology than HIV associated neurocognitive disorder