Management by Individual Cognitive Remediation of Cognitive Disorders of HIV Infected Patients

NCT03639818 | Unknown

• 1 other identifier: 2018-15
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Despite sustained inhibition of viral replication in plasma undergoing treatment, nearly 30% of HIV-infected patients have HIV-related cognitive impairment. To date, no therapeutic strategy has demonstrated clinical efficacy. The initial hypothesis is to use the non-medical techniques of cognitive remediation commonly practiced in the treatment of Alzheimer's disease to allow improvement or even regression of cognitive disorders in HIV-infected people (PHAs) who are virologically tested on antiretroviral combination therapy (ART). Some recent pilot studies using individual computer-based cognitive remediation strategies show improved test performance. However, none have studied the impact of this strategy on PPHIV with cognitive impairment. A single-center pilot study evaluating the efficacy of an individual cognitive remediation program for 6 months on the improvement of cognitive impairment in patients with stable plasma HIV viral load that is undetectable under stable antiretroviral combination (cART) cognitive disorders related to HIV infection. The primary objective is to demonstrate improvement through a 6-month individual cognitive remediation program on cognitive impairment (1 standard deviation variations on 2 M6 neuropsychological tests) in controlled HIV-positive individuals under cART with cognitive disorders related to HIV. Methodology: Monocentric, prospective, pilot study of 40 patients performed in an open period of 25 months. The inclusion period is 13 months and the participation duration per patient is 12 months. After an inclusion visit, patients start 15 days of individual cognitive remediation sessions. The cognitive remediation will be led by a psychologist specialized in neuropsychology, trained and experienced in this method. Cognitive remediation will be performed at a rate of 1 to 2 sessions per week. Each patient will be assessed initially (M0) at 6 months (M6) and 12 months (M12: 6 months after stopping cognitive remediation) with a battery of standardized neuropsychological (NP) tests performed by a neuropsychologist. Primary endpoint: Improved cognitive impairment after 6 months of cognitive remediation, with each patient being their own control, defined by improvement on at least 2 tests of 1 standard deviation minimum.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• number of cognitive disorders

  Improvement of cognitive disorders after 6 months of cognitive remediation, each patient being his own control, defined by the improvement on at least 2 tests of 1 minimum standard deviation.

  6 months

Study Arms (1)

experimental group

EXPERIMENTAL

HIV patients

Other: individual sessions of cognitive remediation

Interventions

individual sessions of cognitive remediation OTHER

The cognitive remediation will be led by a psychologist specialized in neuropsychology, trained and experienced in this method. Cognitive remediation will be performed at a rate of 1 to 2 sessions per week for the duration of the study. This treatment will be carried out individually for half in face-to-face session in the clinical immuno-hematology department, face-to-face with the neuropsychologist, half at home with computer-based home exercises using PRESCO software ® from HAPPYNEURON®

experimental group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive patient1
• With a plasma viral load below the detection threshold for 6 months minimum, with the exception of blips defined by the presence of a detectable viral load \<1000 copies / ml undetectable controlled on another successive collection.
• Triple antiretroviral tritherapy stable for 6 months
• Presenting a cognitive disorder proven by an alteration of at least 2 of the cognitive fields evaluated by psychometric tests for 6 months minimum
• years \<age \<65 years
• Absence of marked depression defined by Beck score \<16 (Appendix 13)
• Affiliated to the social security system,
• ) Having signed the consent form.
• Having made a balance of cognitive disorders eliminating any other cause of cognitive disorders including at least a cerebral MRI or brain CT () injected)
• Familiar with the use of computer tools (Having computer equipment with an internet connection or accepting to come on site to use the software of cognitive remediation exercises)

You may not qualify if:

• Patient with a poor understanding of French,
• Active addiction
• Alcohol dependence
• Patient under guardianship,
• Patient with HIV-related dementia
• Child B or C liver cirrhosis (Appendix 17)
• Severe renal insufficiency (Cockcroft clearance of creatinine \<30 ml / min)
• Any severe clinical event in the opinion of the investigator that could interfere with the strategy under study

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• EMILIE GARRIDO PRADALIE, MD

  APHM

  STUDY DIRECTOR

Central Study Contacts

OLIVIA ZAEGEL, MD

CONTACT

+3349143809; Olivia.ZAEGEL@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: December 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

FR (1)