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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: HIV

Treatments: Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02882230

AMR_2016_13

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 2 patient groups

exposition to the drugs

Description:

patients treated with at least one of the following drugs: dolutegravir, elvitegravir and rilpivirine

Treatment:

Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir

patients non exposed to the drugs