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

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ClinicalTrials.gov Identifier: NCT02882230
Recruitment Status : Not yet recruiting
First Posted : August 29, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.


Condition or disease Intervention/treatment
HIV Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir

Study Type : Observational
Estimated Enrollment : 400 participants
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882230


Contacts
Contact: Laurence SALOMON, MD, PhD 0033148036431 lsalomon@for.paris

Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Antoine MOULIGNIER, MD Fondation Ophtalmologique A. de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02882230     History of Changes
Other Study ID Numbers: AMR_2016_13
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Dolutegravir
Rilpivirine
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors