NEPALE: Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03964584

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

The neurological and psychiatric adverse effects of antiretroviral drugs is a concern for clinicians and people living with HIV. In addition, clinical trials conducted prior to market authorization often have stric inclusion and exclusion criteria in terms of age, co-morbidity or co-medication, and the patients included in the studies are not always representative of the population for whom the drugs will be prescribed in real life. We propose a prospective cohort study to assess the occurrence of neurological and psychiatric adverse events in HIV+ patients starting an association with dolutegravir or bictegravir.

Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.

Condition or Disease	Intervention/Treatment	Phase
HIV+ Patients	Other: assessment of neurological and psychiatric disorders by self-administered questionnaires

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Outcome Measures

Primary Outcome Measures

The presence of at least one of the following neurological or psychiatric disorders [6 months]
depression, defined by a CES-D score ≥ 17 for men and ≥ 23 for women anxiety, defined by a STAI score ≥ 56 (high anxiety); a score > 65 indicating very high anxiety; pathological fatigue, defined by a score on the EMIF-SEP scale ≥ 45/100; presence of a neurological symptom identified by the QES questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Age ≥ 18 years
HIV-infected
Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir

Exclusion criteria:

Intolerance to dolutegravir or bictegravir
Addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles ("poppers") and occasional recreational cannabis
Alcohol consumption >10 standard drinks/week
Active HCV coinfection
Pregnant or breastfeeding woman