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

February 25, 2020 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine
6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • AMR_2016_13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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