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

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria Senese
• Collaborators: Azienda Ospedaliera San Paolo; Catholic University of the Sacred Heart; Ospedale Amedeo di Savoia; Ospedale Policlinico San Martino
• Treatments: Abacavir; Dideoxynucleosides; Dolutegravir; Emtricitabine; Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Tenofovir; Triumeq

Criteria

Inclusion Criteria:

• Age >18 years

• HIV-1 infection

• HIV RNA <50 copies/mL >12 months (including patients with 1 blip 50-200 cp/mL before screening, not confirmed)

• On treatment with dolutegravir/abacavir/lamivudine >6 months

Exclusion Criteria:

• Previous AIDS events

• Pregnancy or pregnancy plan

• Decompensated cirrhosis (B or C CPT status)

• Intake of alcohol, substances, other drugs that may affect neurocognitive performances

• Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir

• Certified diagnosis of major depression, psychosis, history of suicidal attempts

• Treatment with antidepressants or antipsychotic drugs

• History of virological failure with INSTIs

• Lack of knowledge of italian language

• Impossibility to obtain informed written consent

• HBsAg positivity

• Estimated glomerular filtration rate by CK-EPI <50 mL/min per 1.73 m2