Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen — DOBINeuro  

HIV-1-infection Clinical Trial

Official title: The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function

Status Recruiting

Clinical Trial Summary

Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir.

Clinical Trial Description

Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir. The main outcome measure will be a global severity index (GSI) of neuropsychiatric symptoms arising from 10 symptom domains, including somatization, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism. The secondary outcomes are to compare, between arms and during follow up, neuropsychiatric symptoms severity, neurocognitive performance, changes in self-reported symptoms, adherence and HR-QoL, correlation between symptoms (neuropsychiatric and other), drug exposure and HR-QoL, proportion of adverse events, proportion of virological failures and antiretrovirals resistance at virological failure. ;

Related Conditions & MeSH terms

• HIV-1-infection

• NCT number: NCT04155554
• Study type: Interventional
• Source: Azienda Ospedaliera Universitaria Senese
• Contact: Barbara Rossetti, PhD
• Phone: +393201437658
• Email: barbara.rossetti@ao-siena.toscana.it
• Status: Recruiting
• Phase: Phase 3
• Start date: January 29, 2020
• Completion date: July 2021