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

NCT04266002 | Completed

• 1 other identifier: IHFB001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 12

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)

Conditions

HIV-1-infection; HIV Associated Neurocognitive Disorder

Keywords

CNS Penetration Effectiveness; Global Deficit Score; Cytokines; CSF Inflammation

Outcome Measures

Primary Outcomes (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.

  HIV associated neurocognitive disorders classification with Frascati 3-stage

  Change from Baseline to Week 96

Secondary Outcomes (65)

• Demonstrate a significant improvement in HIV associated neurocognitive disorders after ARV intensification with increased CNS Penetration Effectiveness scoring ≥+3 and total CPE score ≥9.

  Change from Baseline to Week 48

• To evaluate HIV associated neurocognitive disorders and Global Deficit Score change

  Change from Baseline to Week 48

• To evaluate HIV associated neurocognitive disorders and Global Deficit Score change

  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

  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

  Change from Baseline to Week 96

Study Arms (1)

HIV-1 infected adult associated neurocognitiv

OTHER

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

Interventions

Validation of Charter score for the CNS diffusion of antiretroviral drugs OTHER

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.

HIV-1 infected adult associated neurocognitiv

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject (male or female) with HIV-1 infection
• Subject is ≥ 18 years of age
• 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

You may not qualify if:

• 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
• 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
• 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
• Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents
• Subject at which the initial lumbar punction can't be achieved
• 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
• Subject under curatorship or guardianship
• Subject at which the initial cerebral MRI can't be achieved

Sponsors & Collaborators

• Hôpital Franco-Britannique-Fondation Cognacq-Jay: lead
• Hospital Ambroise Paré Paris: collaborator

Study Sites (12)

Hôpital d'Argenteuil

Argenteuil, 95100, France

Location

Hôpital Intercommunal Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Centre Hospitalier de Bligny

Briis-sous-Forges, 91640, France

Location

Hôpital Mignot Centre Hospitalier de Versailles

Chesnay, 78150, France

Location

Hôpital Raymond Poincaré

Garches, 92380, France

Location

Centre Hospitalier de Gonesse

Gonesse, 95500, France

Location

Institut Hospitalier Franco- Britannique

Levallois-Perret, 92300, France

Location

Centre Hospitalier Marc Jacquet

Melun, 77000, France

Location

Centre Hospitalier René Dubois

Pontoise, 95300, France

Location

Hôpital Delafontaine

Saint-Denis, 93200, France

Location

Centre Hospitalier Intercommunal de Poissy Germain en Laye

Saint-Germain-en-Laye, 78100, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Study Officials

• Philippe AEGERTER

  Clinical Research Unit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study promotor

Model Details: Prospective Pilot study, open-label, multicenter in the Ile-de-France

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: February 12, 2020
• Study Start: November 1, 2011
• Primary Completion: June 29, 2012
• Study Completion: July 26, 2016
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)