HIV+ Patients
Conditions
Keywords
dolutegravir, dictegravir, Neurological disorder, Psychiatric disorder, HIV integrase Inhibitors, Adverse drug event
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.
Interventions
OTHERassessment of neurological and psychiatric disorders by self-administered questionnaires
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.
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed