HIV
Conditions
Brief summary
The frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. The inclusion and exclusion criteria for enrolling people living with HIV are at times so selective and the subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. These adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments. This study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.
Interventions
DRUGprescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir
chemical dosage ARV
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
* HIV infection * age \> 18 * treatment with rilpivirine, elvitegravir, or dolutegravir (for exposed patients) * treatment with none of these drugs (for non exposed patients) * capacity of reading French language
Exclusion criteria
* drugs addiction (except for amyl nitriles (poppers) and cannabis) * alcoholism * co-infection with hepatitis C virus * pregnant or breast feeding patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients with neurologic and/or psychiatric adverse events | 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine |
Countries
France
Outcome results
None listed