NCT02882230

Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting

Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir	chemical dosage ARV

Timeline

• Start date: 2018-11-19
• Primary completion: 2018-12-03
• Completion: 2019-01-15
• First posted: 2016-08-29
• Last updated: 2020-02-27

Locations

1 site across 1 country: France