HIV+ Patients Clinical Trial
Official title:
Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)
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.
n/a