Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life
- Conditions
- HIV+ Patients
- Registration Number
- NCT03964584
- Lead Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method