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

• Status: Terminated
• Trial end date: 2019-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Treatments: Dolutegravir; Elvitegravir; Polystyrene sulfonic acid; Rilpivirine

Criteria

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