Clinical trial NCT04155554: Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV-1-infection
Keywords: HIV
Neurocognitive functions
Neuropsychiatric side effects
Bictegravir
INSTI
Lead sponsor: Azienda Ospedaliera Universitaria Senese
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
name: Ospedale Policlinico San Martino
name: Azienda Ospedaliera San Paolo
name: Ospedale Amedeo di Savoia
First posted: 2019-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: neuropsychiatric symptoms severity in 3 months
timeFrame: 3 months
Secondary outcomes:
measure: neuropsychiatric symptoms severity in 3 and 12 months
timeFrame: 12 months
measure: Mini International Neuropsychiatric Interview Plus subscale for suicide risk
timeFrame: 12 months
measure: neurocognitive performance
timeFrame: 12 months
measure: neurocognitive impairment and neuropsychiatric symptoms
timeFrame: 12 months
measure: self-reported symptoms (21 items, 0-5 points for each), adherence (0-100%) and HR-QoL (9 items, 0-5 points for each)
timeFrame: 12 months
measure: drug exposure
timeFrame: 12 months
measure: adverse events
timeFrame: 12 months
measure: virological failures
timeFrame: 12 months
measure: Treatment Satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Barbara Rossetti
Study officials:
affiliation: Azienda Ospedaliera Universitaria Senese
name: Barbara Rossetti, PhD
role: PRINCIPAL_INVESTIGATOR
References: