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

February 9, 2020 updated by: Gilles Force, MD, GCS IHFB Cognacq-Jay

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)

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
        • Hopital d'Argenteuil
      • Aulnay-sous-Bois, France, 93602
        • Hôpital Intercommunal Robert Ballanger
      • Briis-sous-Forges, France, 91640
        • Centre Hospitalier de Bligny
      • Chesnay, France, 78150
        • Hôpital Mignot Centre Hospitalier de Versailles
      • Garches, France, 92380
        • Hôpital Raymond Poincaré
      • Gonesse, France, 95500
        • Centre Hospitalier de Gonesse
      • Levallois-Perret, France, 92300
        • Institut Hospitalier Franco- Britannique
      • Melun, France, 77000
        • Centre Hospitalier Marc Jacquet
      • Pontoise, France, 95300
        • Centre Hospitalier René Dubois
      • Saint-Denis, France, 93200
        • Hopital DELAFONTAINE
      • Saint-Germain-en-Laye, France, 78100
        • Centre Hospitalier Intercommunal de Poissy Germain en Laye
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline to Week 96

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline to Week 48
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.
Change from Baseline to Week 48
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.
Change from Baseline to Week 96
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).
Change from Baseline to Week 48
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).
Change from Baseline to Week 96
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.
Change from Baseline to Week 48
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.
Change from Baseline to Week 96
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.
Day 0
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.
Week 48
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.
Week 96
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
Week 12
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
Week 24
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
Week 36
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
Week 48
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
Week 60
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
Week 72
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
Week 84
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
Week 96
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.
Change from Baseline to Week 48
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.
Change from Baseline to Week 96
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.
Change from Baseline to Week 48
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.
Change from Baseline to Week 96
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
Change from Baseline to Week 48
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
Change from Baseline to Week 96
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.
Day 0
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
Change from Baseline to Week 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 24
10-items Cognitive Complaint Questionnaire is altered with a cutoff ≥3
Change from Baseline to Week 24
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
Change from Baseline to Week 36
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
Change from Baseline to Week 48
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
Change from Baseline to Week 60
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
Change from Baseline to Week 72
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
Change from Baseline to Week 84
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
Change from Baseline to Week 96
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
Change from Baseline to Week 12
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
Change from Baseline to Week 24
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
Change from Baseline to Week 36
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
Change from Baseline to Week 48
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
Change from Baseline to Week 60
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
Change from Baseline to Week 72
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
Change from Baseline to Week 84
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
Change from Baseline to Week 96
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
Change from Baseline to Week 12
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
Change from Baseline to Week 24
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
Change from Baseline to Week 36
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
Change from Baseline to Week 48
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
Change from Baseline to Week 60
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
Change from Baseline to Week 72
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
Change from Baseline to Week 84
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
Change from Baseline to Week 96
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)
Change from Baseline to Week 48
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)
Change from Baseline to Week 96
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
Week 12
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
Week 24
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
Week 36
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
Week 48
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
Week 60
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
Week 72
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
Week 84
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
Week 96
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
Day 0
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
Week 4
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
Week 48
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
Week 96
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
Change from Baseline to Week 48
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
Change from Baseline to Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GCS IHFB Cognacq-Jay

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Ambroise Paré Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Philippe AEGERTER, Clinical Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IHFB001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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