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

NCT03964584 | Withdrawn

• 1 other identifier: AMR_2019_1
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV+ Patients

Keywords

dolutegravir; dictegravir; Neurological disorder; Psychiatric disorder; HIV integrase Inhibitors; Adverse drug event

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

assessment of neurological and psychiatric disorders by self-administered questionnaires OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected patients who need to initiate or modify antiretroviral therapy, and starting a combination of antiretroviral agents including dolutegravir or bictegravir.

You may qualify if:

• Age ≥ 18 years
• HIV-infected
• Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

MeSH Terms

Conditions

Nervous System Diseases; Mental Disorders; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 28, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share