CogStim, a Pilot Study : Cognitive Rehabilitation Management of HIV-1 Mild Cognitively Impaired Patients Controlled With Antiretroviral Therapy

HIV Clinical Trial

— CogStim  

Official title:

CogStim, a Pilot Study : Cognitive Rehabilitation Management of HIV-1 Mild Cognitively Impaired Patients Controlled With Antiretroviral Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02343887
• Other study ID #: 2013-49
• Secondary ID: 2013-A01621-44
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2014
• Last updated: October 22, 2015
• Start date: November 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Olivia ZAEGEL- FAUCHER
• Email: olivia.zaegel[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms impact the compliance of the treatment, though its performance and daily life quality. To this day, no therapy tested has proved its efficiency, including the strategy of the antiretroviral therapy (cART) optimization according to the Cerebral Penetration effectiveness Score (CPE).

Description of the study: an open prospective comparative monocentric pilote study, randomised in three groups which investigates the efficiency of a 6 months-cognitive rehabilitation program on improving asymptomatic or minor cognitive disorder for undetectable HIV+ patients. This study gathers HIV-1 patients undetectable under stable cART with a good cerebral penetration who develop asymptomatic or minor cognitive disorders connected to HIV infection. Those who have severe psychiatric disorder or who are on medication that could interfere with psychometrical tests will be excluded.

Main Objective: to compare the impact of a cognitive rehabilitation program over a 6 months period on the evolution of minor cognitive disorders and asymptomatic patients to a control group and a group treated with psychological support.

Description:

This is an open prospective comparative monocentric study, pilote, that randomised 60 patients in three groups of 20. This study will select 18 to 55 years old patients, with HIV infection controlled under antiretroviral therapy stble for 12 months and cognitive impairment objective on two neuropsychological evaluations separated from 6 months at least. All selected patients must have been explored by cerebral RMN or scanner

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• - Seropositive for HIV-1 Patient

• With a plasma viral load below the limit of detection for minimum 6 months (HIV viral load <40 copies / ml)

• On stable antiretroviral therapy for 12 months, according to the revised optimized subject to the constraints of genotypic resistance and CPE score in the absence of cons-indication to treatment intensive brain penetration (Annex 15)

• With cognitive complaint objectified by the cognitive complaint questionnaire (Appendix 9: score 3 or 1 positive response among the items C4, C5, C7, C8) and cognitive impairment found by an alteration of at least two cognitive fields assessed by psychometric tests for at least 6 months

• 18 <age <55 years

• No defined by a marked depression scale score of Beck <16 (Appendix 13)

• No marked anxiety defined by a T score> 55 on the scale of Spielberger STAI-Y (Annex 14)

• Insured under the social security

• Who signed the consent form.

• Recent brain imaging excluding other causes of cognitive impairment (MRI or CT brain injected injected so-indication against MRI)

Exclusion Criteria:

• A patient diagnosed and followed for more than six months psychiatric disorder that could interfere with psychometric assessment

• Patients with a poor understanding of French,

• Patients with active opportunistic infection of the CNS or with neurological sequelae.

• History of head trauma

• Active Substance excluding cannabis

• Patient for which a change of antiretroviral therapy is provided within 12 months

• Patient for which interferon treatment is provided within 12 months

• Patient placed under guardianship,

• Patient with HIV-related dementia

• Liver cirrhosis Child B or C (Annex 16)

• Severe renal impairment (creatinine clearance by Cockcroft <30 ml / min)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• neuropsychological tests

• STAI-Y scale for anxiety

• Beck scale for depression

• without intervention

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive remediation strategy (BREF test)	- BREF test	6 months	No
Primary	cognitive remediation strategy (grooved pegboard test)	- grooved pegboard test	6 months	No
Primary	cognitive remediation strategy (RLRI-16 test6.)	- RLRI-16 test6.	6 months	No
Primary	cognitive remediation strategy (Digit Symbol Substitution Test)	- Digit Symbol Substitution Test	6 months	No
Secondary	impact on daily life quality (SF-12 Medical Outcomes Study Short-Form General Health Survey)	SF-12 Medical Outcomes Study Short-Form General Health Survey"	6 months	No
Secondary	impact on daily life quality (Trail Making Test)	-Trail Making Test	6 months	No