HIV InfectionsCOGSTIM2NCT03639818
Management by Individual Cognitive Remediation of Cognitive Disorders of HIV Infected Patients
A study testing individual sessions of cognitive remediation in people with HIV Infections, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- individual sessions of cognitive remediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2018to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 18 years <age <65 years
- Absence of marked depression defined by Beck score <16 (Appendix 13)
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- 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)
Who cannot join
- Patient with a psychiatric pathology diagnosed and followed for more than 6 months that could interfere with the psychometric evaluation, with the exception of depression with Beck score> 16 on the inclusion report
- Patient with a poor understanding of French,
- Active addiction
- Alcohol dependence
- Patient under guardianship,
- Patient with HIV-related dementia
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
OLIVIA ZAEGEL, MD, +33491343809, Olivia.ZAEGEL@ap-hm.fr
About this study
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.
Read more
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.
Read the detailed description
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:
- Analyze the evolution of cognitive disorders 6 months after stopping cognitive remediation,
- 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
- Determine the most sensitive psychometric tests among those screened for asymptomatic and minor cognitive impairment in the HIV patient
- Evaluate the impact of these therapeutic treatments on the quality of life, social autonomy and self-esteem
- Characterize cognitive impairment in HIV patients according to Frascatti criteria, Glissen criteria and norms routinely used in neuropsychology routinely for each test
- 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.
- Conditions
- HIV Infections
- Being tested
- individual sessions of cognitive remediation
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual sessions of cognitive remediationOther
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®
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | HIV patients Receives: Other: individual sessions of cognitive remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startDec 2018 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, MD, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639818
- Sponsor's protocol ID
- 2018-15
- Acronym
- COGSTIM2
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGSTIM 2 Study: Management by Individual Cognitive Remediation of Cognitive Disorders of HIV Infected Patients Controlled by Antiretroviral Treatment
- ClinicalTrials.gov ID
- NCT03639818
- Acronym / sponsor ID
- COGSTIM2 / 2018-15
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Analyze the evolution of cognitive disorders 6 months after stopping cognitive remediation,
- 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
- Determine the most sensitive psychometric tests among those screened for asymptomatic and minor cognitive impairment in the HIV patient
- Evaluate the impact of these therapeutic treatments on the quality of life, social autonomy and self-esteem
- Characterize cognitive impairment in HIV patients according to Frascatti criteria, Glissen criteria and norms routinely used in neuropsychology routinely for each test
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: individual sessions of cognitive remediationHIV patients |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 18 years <age <65 years
Key exclusion criteria (9 listed)
- Patient with a psychiatric pathology diagnosed and followed for more than 6 months that could interfere with the psychometric evaluation, with the exception of depression with Beck score> 16 on the inclusion report
- Patient with a poor understanding of French,
- Active addiction
- Alcohol dependence
- Patient under guardianship,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual sessions of cognitive remediationThe 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® | Other | experimental group |
Primary outcome
number of cognitive disorders
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE, MD study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual sessions of cognitive remediation in people with HIV Infections, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OLIVIA ZAEGEL, MD (+3349143809, Olivia.ZAEGEL@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of cognitive disorders (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.