NCT02343887

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• HIV

Interventions

Type	Name	Description
OTHER	neuropsychological tests
OTHER	STAI-Y scale for anxiety
OTHER	Beck scale for depression
OTHER	without intervention

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-01-01
• Completion: 2017-10-01
• First posted: 2015-01-22
• Last updated: 2015-10-23

Locations

1 site across 1 country: France