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

HIV Clinical Trial

— NEPAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02882230
• Other study ID #: AMR_2016_13
• Status: Terminated
• Start date: November 19, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: February 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 15, 2019
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir
chemical dosage ARV

Locations

Country	Name	City	State
France	France	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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