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

Azienda Ospedaliera Universitaria Senese

Status and phase: Unknown; Phase 3

Conditions: HIV-1-infection

Treatments: Drug: Dolutegravir/lamivudine/abacavir; Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04155554

2018-004885-32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Bictegravir/emtricitabine/tenofovir alafenamide

Experimental group

Description:

Patients with suppressed viral load switching from dolutegravur/lamivudina/abacavir (50/300/600 mg) 1 tablet OD to bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg) 1 tablet OD

Treatment:

Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Dolutegravir/lamivudine/abacavir

Active Comparator group

Description:

Patients with suppressed viral load continuing dolutegravir/lamivudine/abacavir (50/300/600 mg) 1 tablet OD

Treatment:

Drug: Dolutegravir/lamivudine/abacavir