Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

HIV-1 Infected Adult Subjects With HIV-associated Neurocognitive Disorders Despite Effective Antiretroviral Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266002
Recruitment Status : Completed
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Hospital Ambroise Paré Paris
Information provided by (Responsible Party):
Gilles Force, MD, GCS IHFB Cognacq-Jay

Tracking Information
First Submitted Date  ICMJE January 24, 2020
First Posted Date  ICMJE February 12, 2020
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE November 1, 2011
Actual Primary Completion Date June 29, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2020)
Demonstrate a significant improvement in HIV associated neurocognitive disorders after ARV intensification with increased CNS Penetration Effectiveness scoring ≥+3 and total CPE score ≥9. [ Time Frame: Change from Baseline to Week 96 ]
HIV associated neurocognitive disorders classification with Frascati 3-stage
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2020)
  • Demonstrate a significant improvement in HIV associated neurocognitive disorders after ARV intensification with increased CNS Penetration Effectiveness scoring ≥+3 and total CPE score ≥9. [ Time Frame: Change from Baseline to Week 48 ]
    HIV associated neurocognitive disorders classification with Frascati 3-stage
  • To evaluate HIV associated neurocognitive disorders and Global Deficit Score change [ Time Frame: Change from Baseline to Week 48 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification. Global Deficit Score (from 0 with no deficit to 5 with high neurocognitive disorder) is calculated with the results of 10 standardized battery tests.
  • To evaluate HIV associated neurocognitive disorders and Global Deficit Score change [ Time Frame: Change from Baseline to Week 96 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification. Global Deficit Score (from 0 with no deficit to 5 with high neurocognitive disorder) is calculated with the results of 10 standardized battery tests.
  • To evaluate the evolution of HIV associated neurocognitive disorders with changes in CD4 and CD8 cells in plasma cells, and plasma HIV-1 viral loads [ Time Frame: Change from Baseline to Week 48 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. CD4 and CD8 cells are measured in plasma with flow cytometry (results in cells/µL).
  • To evaluate the evolution of HIV associated neurocognitive disorders with changes in CD4 and CD8 cells in plasma cells, and plasma HIV-1 viral loads [ Time Frame: Change from Baseline to Week 96 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. CD4 and CD8 cells are measured in plasma with flow cytometry (results in cells/µL).
  • To evaluate the evolution of HIV associated neurocognitive disorders with plasma HIV-1 viral load cells, and plasma HIV-1 viral loads [ Time Frame: Change from Baseline to Week 48 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. Plasma HIV-1 viral load will be measured with an ultra-sensitive technique with a threshold of 5 copies/mL.
  • To evaluate the evolution of HIV associated neurocognitive disorders with plasma HIV-1 viral load cells, and plasma HIV-1 viral loads [ Time Frame: Change from Baseline to Week 96 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. Plasma HIV-1 viral load will be measured with an ultra-sensitive technique with a threshold of 5 copies/mL.
  • To compare HIV associated neurocognitive disorders in HIV-1 infected patients with detectable and undetectable viral load in CSF [ Time Frame: Day 0 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score.Detectable viral load in CSF is defined as a result >5 copies/mL with ultrasensitive HIV-RNA measure.
  • To compare HIV associated neurocognitive disorders in HIV-1 infected patients with detectable and undetectable viral load in CSF [ Time Frame: Week 48 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score.Detectable viral load in CSF is defined as a result >5 copies/mL with ultrasensitive HIV-RNA measure.
  • To compare HIV associated neurocognitive disorders in HIV-1 infected patients with detectable and undetectable viral load in CSF [ Time Frame: Week 96 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score.Detectable viral load in CSF is defined as a result >5 copies/mL with ultrasensitive HIV-RNA measure.
  • To evaluate the patterns of viral genotypic resistance in patients with virologic failure in blood or CSF [ Time Frame: Week 12 ]
    Virologic failure in the blood is defined as two results >100 copies/mL within one month. Virologic failure in the CSF is defined as a result >100 copies/mL
  • To evaluate the patterns of viral genotypic resistance in patients with virologic failure in blood or CSF [ Time Frame: Week 24 ]
    Virologic failure in the blood is defined as two results >100 copies/mL within one month. Virologic failure in the CSF is defined as a result >100 copies/mL
  • To evaluate the patterns of viral genotypic resistance in patients with virologic failure in blood or CSF [ Time Frame: Week 36 ]
    Virologic failure in the blood is defined as two results >100 copies/mL within one month. Virologic failure in the CSF is defined as a result >100 copies/mL
  • To evaluate the patterns of viral genotypic resistance in patients with virologic failure in blood or CSF [ Time Frame: Week 48 ]
    Virologic failure in the blood is defined as two results >100 copies/mL within one month. Virologic failure in the CSF is defined as a result >100 copies/mL
  • To evaluate the patterns of viral genotypic resistance in patients with virologic failure in blood or CSF [ Time Frame: Week 60 ]
    Virologic failure in the blood is defined as two results >100 copies/mL within one month. Virologic failure in the CSF is defined as a result >100 copies/mL
  • To evaluate the patterns of viral genotypic resistance in patients with virologic failure in blood or CSF [ Time Frame: Week 72 ]
    Virologic failure in the blood is defined as two results >100 copies/mL within one month. Virologic failure in the CSF is defined as a result >100 copies/mL
  • To evaluate the patterns of viral genotypic resistance in patients with virologic failure in blood or CSF [ Time Frame: Week 84 ]
    Virologic failure in the blood is defined as two results >100 copies/mL within one month. Virologic failure in the CSF is defined as a result >100 copies/mL
  • To evaluate the patterns of viral genotypic resistance in patients with virologic failure in blood or CSF [ Time Frame: Week 96 ]
    Virologic failure in the blood is defined as two results >100 copies/mL within one month. Virologic failure in the CSF is defined as a result >100 copies/mL
  • To evaluate the evolution of HIV associated neurocognitive disorders with the evolution of markers in CSF: neopterin, neurofilament light chain (NFL), CCL2, IL6, IL8, CXCL10, soluble CD14 [ Time Frame: Change from Baseline to Week 48 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. CSF biomarkers were obtained using high-performance liquid chromatography coupled with fluorimetric detection for neopterin (nmol/L), using the Quanterix® single molecule array platform for neurofilament light protein (NF-L)(pg/mL), chemokine (C-C-motif) ligand-2 (CCL2)(pg/mL), interleukine 6 (IL6)(pg/mL), interleukine 8 (IL8)(pg/mL), chemokine (C-X-C-motif) ligand-10 (CXCL10)(pg/mL), and using an enzyme-linked immunosorbent assay (Biotechne®) for soluble CD14 (sCD14)(µg/mL) levels.
  • To evaluate the evolution of HIV associated neurocognitive disorders with the evolution of markers in CSF: neopterin, neurofilament light chain (NFL), CCL2, IL6, IL8, CXCL10, soluble CD14 [ Time Frame: Change from Baseline to Week 96 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. CSF biomarkers were obtained using high-performance liquid chromatography coupled with fluorimetric detection for neopterin (nmol/L), using the Quanterix® single molecule array platform for neurofilament light protein (NF-L)(pg/mL), chemokine (C-C-motif) ligand-2 (CCL2)(pg/mL), interleukine 6 (IL6)(pg/mL), interleukine 8 (IL8)(pg/mL), chemokine (C-X-C-motif) ligand-10 (CXCL10)(pg/mL), and using an enzyme-linked immunosorbent assay (Biotechne®) for soluble CD14 (sCD14)(µg/mL) levels.
  • To evaluate the evolution of HIV associated neurocognitive disorders with the evolution of markers in plasma: neopterin, neurofilament light chain (NFL), CCL2, IL6, IL8, CXCL10, soluble CD14 [ Time Frame: Change from Baseline to Week 48 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. Plasma biomarkers were obtained using high-performance liquid chromatography coupled with fluorimetric detection for neopterin (nmol/L), using the Quanterix® single molecule array platform for neurofilament light protein (NF-L)(pg/mL), chemokine (C-C-motif) ligand-2 (CCL2)(pg/mL), interleukine 6 (IL6)(pg/mL), interleukine 8 (IL8)(pg/mL), chemokine (C-X-C-motif) ligand-10 (CXCL10)(pg/mL), and using an enzyme-linked immunosorbent assay (Biotechne®) for soluble CD14 (sCD14)(µg/mL) levels.
  • To evaluate the evolution of HIV associated neurocognitive disorders with the evolution of markers in plasma: neopterin, neurofilament light chain (NFL), CCL2, IL6, IL8, CXCL10, soluble CD14 [ Time Frame: Change from Baseline to Week 96 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. Plasma biomarkers were obtained using high-performance liquid chromatography coupled with fluorimetric detection for neopterin (nmol/L), using the Quanterix® single molecule array platform for neurofilament light protein (NF-L)(pg/mL), chemokine (C-C-motif) ligand-2 (CCL2)(pg/mL), interleukine 6 (IL6)(pg/mL), interleukine 8 (IL8)(pg/mL), chemokine (C-X-C-motif) ligand-10 (CXCL10)(pg/mL), and using an enzyme-linked immunosorbent assay (Biotechne®) for soluble CD14 (sCD14)(µg/mL) levels.
  • To evaluate HIV associated neurocognitive disorders and Brain MRI change [ Time Frame: Change from Baseline to Week 48 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. Brain MRI is performed before and after ARV change
  • To evaluate HIV associated neurocognitive disorders and Brain MRI change [ Time Frame: Change from Baseline to Week 96 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. Brain MRI is performed before and after ARV change
  • To compare sensitivity and specificity of the 2 screening tests (FAB test and Modified - HIV Dementia Scale) for the diagnosis of HAND [ Time Frame: Day 0 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. Altered Frontal Assessment Battery test is defined with a score ≤15/18 and altered modified-HIV Dementia Scale screening test is defined with a score ≤10/12.
  • To evaluate regular monitoring of cognitive impairment by 10-items Cognitive Complaint Questionnaire to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 12 ]
    10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
  • To evaluate regular monitoring of cognitive impairment by 10-items Cognitive Complaint Questionnaire to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 24 ]
    10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
  • To evaluate regular monitoring of cognitive impairment by 10-items Cognitive Complaint Questionnaire to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 36 ]
    10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
  • To evaluate regular monitoring of cognitive impairment by 10-items Cognitive Complaint Questionnaire to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 48 ]
    10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
  • To evaluate regular monitoring of cognitive impairment by 10-items Cognitive Complaint Questionnaire to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 60 ]
    10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
  • To evaluate regular monitoring of cognitive impairment by 10-items Cognitive Complaint Questionnaire to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 72 ]
    10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
  • To evaluate regular monitoring of cognitive impairment by 10-items Cognitive Complaint Questionnaire to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 84 ]
    10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
  • To evaluate regular monitoring of cognitive impairment by 10-items Cognitive Complaint Questionnaire to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 96 ]
    10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
  • To evaluate regular monitoring of cognitive impairment by Inventory of Activity Daily Living part II to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 12 ]
    Inventory of Activity Daily Living part II is altered with a cutoff ≥2
  • To evaluate regular monitoring of cognitive impairment by Inventory of Activity Daily Living part II to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 24 ]
    Inventory of Activity Daily Living part II is altered with a cutoff ≥2
  • To evaluate regular monitoring of cognitive impairment by Inventory of Activity Daily Living part II to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 36 ]
    Inventory of Activity Daily Living part II is altered with a cutoff ≥2
  • To evaluate regular monitoring of cognitive impairment by Inventory of Activity Daily Living part II to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 48 ]
    Inventory of Activity Daily Living part II is altered with a cutoff ≥2
  • To evaluate regular monitoring of cognitive impairment by Inventory of Activity Daily Living part II to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 60 ]
    Inventory of Activity Daily Living part II is altered with a cutoff ≥2
  • To evaluate regular monitoring of cognitive impairment by Inventory of Activity Daily Living part II to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 72 ]
    Inventory of Activity Daily Living part II is altered with a cutoff ≥2
  • To evaluate regular monitoring of cognitive impairment by Inventory of Activity Daily Living part II to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 84 ]
    Inventory of Activity Daily Living part II is altered with a cutoff ≥2
  • To evaluate regular monitoring of cognitive impairment by Inventory of Activity Daily Living part II to detect at the earliest possible changes in cognitive status [ Time Frame: Change from Baseline to Week 96 ]
    Inventory of Activity Daily Living part II is altered with a cutoff ≥2
  • To evaluate the Quality of Life during the study [ Time Frame: Change from Baseline to Week 12 ]
    Quality of Life is measured by Short Form 36 Health Survey
  • To evaluate the Quality of Life during the study [ Time Frame: Change from Baseline to Week 24 ]
    Quality of Life is measured by Short Form 36 Health Survey
  • To evaluate the Quality of Life during the study [ Time Frame: Change from Baseline to Week 36 ]
    Quality of Life is measured by Short Form 36 Health Survey
  • To evaluate the Quality of Life during the study [ Time Frame: Change from Baseline to Week 48 ]
    Quality of Life is measured by Short Form 36 Health Survey
  • To evaluate the Quality of Life during the study [ Time Frame: Change from Baseline to Week 60 ]
    Quality of Life is measured by Short Form 36 Health Survey
  • To evaluate the Quality of Life during the study [ Time Frame: Change from Baseline to Week 72 ]
    Quality of Life is measured by Short Form 36 Health Survey
  • To evaluate the Quality of Life during the study [ Time Frame: Change from Baseline to Week 84 ]
    Quality of Life is measured by Short Form 36 Health Survey
  • To evaluate the Quality of Life during the study [ Time Frame: Change from Baseline to Week 96 ]
    Quality of Life is measured by Short Form 36 Health Survey
  • To compare HIV associated neurocognitive disorders in patients with great CPE change ≥5 and patients with low CPE change (+3 or +4) [ Time Frame: Change from Baseline to Week 48 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. CPE changes are analysed with most recent genotypic algorithm (v.2016)
  • To compare HIV associated neurocognitive disorders in patients with great CPE change ≥5 and patients with low CPE change (+3 or +4) [ Time Frame: Change from Baseline to Week 96 ]
    HIV associated neurocognitive disorders are measured with Frascati 3-stage classification and Global Deficit Score. CPE changes are analysed with most recent genotypic algorithm (v.2016)
  • To study the incidence and severity of adverse events during the study period [ Time Frame: Week 12 ]
    Neurologic or neuropsychologic adverse events are particularly analysed
  • To study the incidence and severity of adverse events during the study period [ Time Frame: Week 24 ]
    Neurologic or neuropsychologic adverse events are particularly analysed
  • To study the incidence and severity of adverse events during the study period [ Time Frame: Week 36 ]
    Neurologic or neuropsychologic adverse events are particularly analysed
  • To study the incidence and severity of adverse events during the study period [ Time Frame: Week 48 ]
    Neurologic or neuropsychologic adverse events are particularly analysed
  • To study the incidence and severity of adverse events during the study period [ Time Frame: Week 60 ]
    Neurologic or neuropsychologic adverse events are particularly analysed
  • To study the incidence and severity of adverse events during the study period [ Time Frame: Week 72 ]
    Neurologic or neuropsychologic adverse events are particularly analysed
  • To study the incidence and severity of adverse events during the study period [ Time Frame: Week 84 ]
    Neurologic or neuropsychologic adverse events are particularly analysed
  • To study the incidence and severity of adverse events during the study period [ Time Frame: Week 96 ]
    Neurologic or neuropsychologic adverse events are particularly analysed
  • To study the trough levels of antiretroviral drugs in blood and cerebrospinal fluid during the study [ Time Frame: Day 0 ]
    ARV concentrations were determined using an ultra-performance liquid chromatography coupled with tandem mass spectrometry
  • To study the trough levels of antiretroviral drugs in blood after ARV change [ Time Frame: Week 4 ]
    ARV concentrations were determined using an ultra-performance liquid chromatography coupled with tandem mass spectrometry
  • To study the trough levels of antiretroviral drugs in blood and cerebrospinal fluid during the study [ Time Frame: Week 48 ]
    ARV concentrations were determined using an ultra-performance liquid chromatography coupled with tandem mass spectrometry
  • To study the trough levels of antiretroviral drugs in blood and cerebrospinal fluid during the study [ Time Frame: Week 96 ]
    ARV concentrations were determined using an ultra-performance liquid chromatography coupled with tandem mass spectrometry
  • To study the cardiovascular risk evolution [ Time Frame: Change from Baseline to Week 48 ]
    Cardiovascular risk is measured with Framingham score, Systematic Coronary Risk Estimation, and D:A:D study model score
  • To study the cardiovascular risk evolution [ Time Frame: Change from Baseline to Week 96 ]
    Cardiovascular risk is measured with Framingham score, Systematic Coronary Risk Estimation, and D:A:D study model score are calcul
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV-1 Infected Adult Subjects With HIV-associated Neurocognitive Disorders Despite Effective Antiretroviral Therapy
Official Title  ICMJE Prospective Study in HIV-1 Infected Adult Subjects With HIV-associated Neurocognitive Disorders Despite Effective Antiretroviral Therapy in Plasma, After a Change in HIV Treatment With an Increased of CHARTER Score ≥ 3 (Total Score ≥ 9)
Brief Summary 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)
Detailed Description Neurocognitive disorders are measured using Frascati 3-stage classification and Global Deficit Score, after the following 10 standardized battery test: Grooved Pegboard for dominant and non-dominant hand, Grefex Verbal Fluency, California Verbal Learning Test (CVLT), Digit Span Wechsler Adult Intelligence Scale III, modified Paced Auditory Serial Addition Test (60 items), WAIS III Digit Symbol Test, Trail Making Test A&B, recall of CVLT and Wisconsin Card Sorting Test; and after the Beck Depression Inventory II (BDI), Inventory of Activity Daily Living part II (IADL) and 10-items Cognitive Complaint Questionnaire (CCQ). The global CNS Penetration Effectiveness (CPE) score of ARV treatment are the sum of the scores of each ARV the patient received, according to the last published scoring. For each drug class, we considered treatment intensification only for drugs with CPE score reaching at least 3 (no intensification if switch in same drug class with same CPE score). CPE score was corrected by drugs resistance status, using cumulative genotype interpreted with the 2012 ANRS algorithm (www.hivfrenchresistance.org; v.2012) at inclusion (CPE=0 if resistance).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Pilot study, open-label, multicenter in the Ile-de-France
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV-1-infection
  • HIV Associated Neurocognitive Disorder
Intervention  ICMJE Other: Validation of Charter score for the CNS diffusion of antiretroviral drugs
IHFB001 (Neuroplustrois) is a pilot study, phase IV, open-label, multicenter in Ile-de-France region, trying to demonstrate the improvement of cognitive change after treatment characterized by its better diffusion in the central nervous system. The characteristics of the change in treatment are (Cn - Ci) ≥ 3 and Cn ≥ 9, where Cn is the Charter score of the new treatment and Ci the Charter score of the initial treatment.
Study Arms  ICMJE HIV-1 infected adult associated neurocognitiv
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 with Global Deficit Score and HAND classification, 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)
Intervention: Other: Validation of Charter score for the CNS diffusion of antiretroviral drugs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2020)
31
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 26, 2016
Actual Primary Completion Date June 29, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04266002
Other Study ID Numbers  ICMJE IHFB001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilles Force, MD, GCS IHFB Cognacq-Jay
Study Sponsor  ICMJE GCS IHFB Cognacq-Jay
Collaborators  ICMJE Hospital Ambroise Paré Paris
Investigators  ICMJE
Study Director: Philippe AEGERTER Clinical Research Unit
PRS Account GCS IHFB Cognacq-Jay
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP