Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life

HIV+ Patients Clinical Trial

— NEPALE  

Official title:

Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03964584
• Other study ID #: AMR_2019_1
• Status: Withdrawn
• Start date: September 1, 2019
• Est. completion date: September 1, 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 neurological and psychiatric adverse effects of antiretroviral drugs is a concern for clinicians and people living with HIV. In addition, clinical trials conducted prior to market authorization often have stric inclusion and exclusion criteria in terms of age, co-morbidity or co-medication, and the patients included in the studies are not always representative of the population for whom the drugs will be prescribed in real life. We propose a prospective cohort study to assess the occurrence of neurological and psychiatric adverse events in HIV+ patients starting an association with dolutegravir or bictegravir.

Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age = 18 years

• HIV-infected

• Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir

Exclusion criteria:

• Intolerance to dolutegravir or bictegravir

• Addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles ("poppers") and occasional recreational cannabis

• Alcohol consumption >10 standard drinks/week

• Active HCV coinfection

• Pregnant or breastfeeding woman

Related Conditions & MeSH terms

• HIV+ Patients

Intervention

Other:
• assessment of neurological and psychiatric disorders by self-administered questionnaires
Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of at least one of the following neurological or psychiatric disorders	depression, defined by a CES-D score = 17 for men and = 23 for women; anxiety, defined by a STAI score = 56 (high anxiety); a score > 65 indicating very high anxiety; pathological fatigue, defined by a score on the EMIF-SEP scale = 45/100; presence of a neurological symptom identified by the QES questionnaire.	6 months