CogStim, a Pilot Study : Cognitive Rehabilitation Management of HIV-1 Mild Cognitively Impaired Patients Controlled With Antiretroviral Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- cognitive remediation strategy (BREF test)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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)
排除标准
- •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)
结局指标
主要结局
cognitive remediation strategy (BREF test)
时间窗: 6 months
- BREF test
cognitive remediation strategy (RLRI-16 test6.)
时间窗: 6 months
- RLRI-16 test6.
cognitive remediation strategy (Digit Symbol Substitution Test)
时间窗: 6 months
- Digit Symbol Substitution Test
cognitive remediation strategy (grooved pegboard test)
时间窗: 6 months
- grooved pegboard test
次要结局
- impact on daily life quality (Trail Making Test)(6 months)
- impact on daily life quality (SF-12 Medical Outcomes Study Short-Form General Health Survey)(6 months)