HIV Infections Clinical Trial
Official title:
COGSTIM 2 Study: Management by Individual Cognitive Remediation of Cognitive Disorders of HIV Infected Patients Controlled by Antiretroviral Treatment
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.
Background: 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 or traumatic brain injury to allow improvement or even regression of
cognitive disorders in HIV-infected people (PHAs) who are virologically tested on
antiretroviral combination therapy (ART). If this hypothesis is validated, this study will
develop additional care structures and / or skills for the management of these cognitive
disorders. 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.
Study description: 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. Cognitive remediation will
be based on individual face-to-face cognitive remediation sessions with a neuropsychologist
and on patients with severe psychiatric conditions or treatments that may interfere with
neuropsychological (NP) testing. this search.
Main Objective: 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.
Secondary objectives:
1. Analyze the evolution of cognitive disorders 6 months after stopping cognitive
remediation,
2. To analyze the evolution of the cognitive disorders in the cases of a duration of the
remediation inferior to 6 months and superior to 2 months
3. Determine the most sensitive psychometric tests among those screened for asymptomatic
and minor cognitive impairment in the HIV patient
4. Evaluate the impact of these therapeutic treatments on the quality of life, social
autonomy and self-esteem
5. Characterize cognitive impairment in HIV patients according to Frascatti criteria,
Glissen criteria and norms routinely used in neuropsychology routinely for each test
6. Describe the risk factors and co-morbidities associated with cognitive impairment
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 (inclusion and non-inclusion criteria checks, data
collection, clinical examination, psychometric test battery, Beck's scale and STAI-Y for
evaluation of anode-depressive symptoms), 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 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®. 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.
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