Clinical Trials

MainTitle

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

This study has been terminated
( Unfavourable opinion of ethical comittee for Amendment Nr 3 )

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild


Information provided by (Responsible Party)
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier
NCT02882230

First received: August 22, 2016
Last updated: February 25, 2020
Last Verified: February 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting

Further study details as provided by Fondation Ophtalmologique Adolphe de Rothschild:

Primary Outcome Measures

  • 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 ]

Enrollment: 1
Study Start Date: November 19, 2018
Study Completion Date: January 15, 2019
Estimated Primary Completion Date: December 3, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02882230

Locations

France
France
Paris, France

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

Principal Investigator: Antoine MOULIGNIER, MD Fondation Ophtalmologique A. de Rothschild
More Information

More Information


Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild  
ClinicalTrials.gov Identifier: NCT02882230   History of Changes  
Other Study ID Numbers: AMR_2016_13  
Study First Received: August 22, 2016  
Last Updated: February 25, 2020  

Additional relevant MeSH terms:
Dolutegravir
Rilpivirine

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.