Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents
Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents. Relationship With Clinical and Sociodemographic Variables
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The aim of this study is to investigate the effect that the eradication of the HCV has on cognition, quality of life and psychopathology. At the same time, investigators intend to study the association between cognitive changes and some clinical variables.
The sample consists of 80 subjects (40 HCV patients and 40 HCV patients coinfected with the Human Immunodeficiency Virus, HIV). Exclusion criteria: Cirrhosis, presence of minimal hepatic encephalopathy or active drug consumption.
A neuropsychological assessment is made before the treatment with direct antiviral agents to evaluate memory, executive functions, processing speed, anxiety, depression and quality of life. Additionally, the following clinical variables are collected: Viral charge, immunosuppression (measured with T Cells CD4 (CD4), CD4 nadir and T Cells CD8 (CD8)) and fibrosis level, HCV genotype and plasma biomarkers: Brain-Derived Neurotrophic Factor (BDNF), Interleukine 6 (IL6), Tumor Necrosis Factor (TNF-a),Glial fibrillary acidic protein (GFAP), Soluble CD14 (SCD14), Neuro-specific enolase (NSE).
The second neuropsychological assessment and clinical data collection is carried out after treatment, concretely 6 months after HCV is undetectable in plasma.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients over 18 years old with indication to receive antiviral treatment
- Diagnosis of chronic infection by hepatitis C virus in the fibrous phase F3 or F4 that have not presented any clinical decompensation of their liver disease, with or without HIV co-infection
Exclusion Criteria:
- Active alcohol consumption> 40g daily or history of chronic alcoholism
- Active consumption of other toxics (heroin, cocaine, cannabis)
- Patients with minimum hepatic encephalopathy
- Background of cerebral neurological disease, chronic renal insufficiency and / or psychiatric illnesses assessed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, which can affect cognitive functions.
- Active use of psychotropics or benzodiazepines
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Memory tests
Délai: baseline, change at 6 months after treatment
|
Rey Auditory Verbal Learning Test (RVLT, Spreen & Strauss 1998) assesses verbal learning, recall and recognition memory; Wechsler Adults Intelligence Scale III backward digits subtest (WAIS, Wechsler 1997) assesses working memory.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single memory component.
|
baseline, change at 6 months after treatment
|
|
Attention tests
Délai: baseline, change at 6 months after treatment
|
Continous Performance Test (CPT, Conners 2000) assesses sustained attention, inattentiveness and impulsivity; WAIS forward digits subtest (WAIS III, Wechsler 1997) assesses attention.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single attention component.
|
baseline, change at 6 months after treatment
|
|
Executive function tests
Délai: baseline, change at 6 months after treatment
|
Stroop Test (Stroop, 1935) assesses flexibility and inhibition of automatic responses; Trail Making Test (TMTA-B Reitan, 1993) assesses visual tracking and flexibility, phonetic and semantic fluency tests (Lezak, 1995) assess verbal fluency; Tower of London (Culbertson & Zillmer, 2005) assesses visual reasoning and planification.
All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single executive function component.
|
baseline, change at 6 months after treatment
|
|
Speed processing test
Délai: baseline, change at 6 months after treatment
|
Digit symbol test (WAIS III, Wechsler 1997) assesses visuomotor speed.
The direct scores have been transformed into T-scores (mean=50; SD=10).
|
baseline, change at 6 months after treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Délai: baseline, change at 6 months after treatment
|
It is a self-registering scale of 14 items: 7 items evaluating anxiety and 7 items evaluating depression (Zigmond & Snaith, 1983). Scoring range: 0-21 for each subscale. Scores >10 in each subscale imply a significant anxious/depressive symptomatology. |
baseline, change at 6 months after treatment
|
|
36-Item Short Form Health Survey (SF-36 )
Délai: baseline, change at 6 months after treatment
|
It is a self-registered scale for the assessment of quality of life ( Alonso y cols.
, 1995).
It consists on 8 dimensions: Physical functioning, limitations for physical issues, corporal pain, social functioning, mental health, limitations for emotional issues, vitality and general perception of the own health.
For each dimension, the scoring range goes from 0 to 100, where higher values represent better outcome (better quality of life/less limitations/better functioning).
|
baseline, change at 6 months after treatment
|
|
Fibroscan
Délai: Baseline, change at 6 months after treatment
|
Degree of fibrosis: Speed of propagation of elastic waves measured with fibroscan.
|
Baseline, change at 6 months after treatment
|
|
HCV RNA
Délai: Baseline, change at 3 months after treatment, change at 6 months after treatment.
|
Viral load quantity measured by plasma HCV RNA is collected in HIV co-infected patients
|
Baseline, change at 3 months after treatment, change at 6 months after treatment.
|
|
Immunosuppression state
Délai: Baseline
|
The next cells were analyzed in blood, in HIV co-infected patients : CD4, %CD4, nadir CD4, CD8, % CD8, CD4/CD8 ratio.
|
Baseline
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood Biomarkers measures
Délai: 1 day pretreatment and change at 6 months post treatment
|
The next blood biomarkers were collected: Brain-derived neurotrophic factor (BDNF); Interleukine 6 (Il-6); Tumor Necrosis Factor (TNF-a ); Glial fibrillary acidic protein (GFAP); Soluble SCD 14 (sCD14) ; Neuro-specific enolase (NSE).
|
1 day pretreatment and change at 6 months post treatment
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CIR2015/042
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Co-infection par le VHC
-
University of Colorado, DenverComplétéCoinfection hépatite C et VIHÉtats-Unis
-
BiocadComplétéHépatite | Hépatite C | Coinfection hépatite C/virus de l'immunodéficience humaineFédération Russe