Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting (NEPAL)
|ClinicalTrials.gov Identifier: NCT02882230|
Recruitment Status : Suspended (Unfavourable opinion for Amendment No. 3)
First Posted : August 29, 2016
Last Update Posted : January 14, 2019
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|
|Official Title:||Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting|
|Actual Study Start Date :||November 19, 2018|
|Actual Primary Completion Date :||December 3, 2018|
|Estimated Study Completion Date :||June 3, 2020|
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|
- 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 ]
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
|Principal Investigator:||Antoine MOULIGNIER, MD||Fondation Ophtalmologique A. de Rothschild|