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

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

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.

Study Overview

• Status: Terminated
• Conditions: HIV
• Intervention / Treatment: Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Paris, France
    • France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV patients with a prescription of rilpivirine, elvitegravir, or dolutegravir (modification or initiation of an antiretroviral treatment) and non exposed HIV patients, who don't take these drugs.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
exposition to the drugs; patients treated with at least one of the following drugs: dolutegravir, elvitegravir and rilpivirine	Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir; chemical dosage ARV
patients non exposed to the drugs

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2018
• Primary Completion (ACTUAL): December 3, 2018
• Study Completion (ACTUAL): January 15, 2019

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (ESTIMATE): August 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Dolutegravir; Rilpivirine; Elvitegravir
• Other Study ID Numbers: AMR_2016_13