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

NCT ID: NCT04155554

Last Updated: 2020-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-29

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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HIV-1-infection

Keywords

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HIV Neurocognitive functions Neuropsychiatric side effects Bictegravir INSTI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bictegravir/emtricitabine/tenofovir alafenamide

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

Group Type EXPERIMENTAL

Bictegravir/emtricitabine/tenofovir alafenamide

Intervention Type DRUG

Switch patients from dolutegravir/lamivudine/abacavir to bictegravir/emtricitabine/tenefovir alafenamide to study neuropsychiatric side effects and neurocognitive function

Dolutegravir/lamivudine/abacavir

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

Group Type ACTIVE_COMPARATOR

Dolutegravir/lamivudine/abacavir

Intervention Type DRUG

Continuing dolutegravir/lamivudine/abacavir to study neuropsychiatric side effects and neurocognitive function

Interventions

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Bictegravir/emtricitabine/tenofovir alafenamide

Switch patients from dolutegravir/lamivudine/abacavir to bictegravir/emtricitabine/tenefovir alafenamide to study neuropsychiatric side effects and neurocognitive function

Intervention Type DRUG

Dolutegravir/lamivudine/abacavir

Continuing dolutegravir/lamivudine/abacavir to study neuropsychiatric side effects and neurocognitive function

Intervention Type DRUG

Other Intervention Names

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Biktarvy Triumeq

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role collaborator

Ospedale Policlinico San Martino

OTHER

Sponsor Role collaborator

Azienda Ospedaliera San Paolo

OTHER

Sponsor Role collaborator

Ospedale Amedeo di Savoia

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Senese

OTHER

Sponsor Role lead

Responsible Party

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Barbara Rossetti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Rossetti, PhD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Senese

Locations

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Barbara Rossetti

Siena, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Barbara Rossetti, PhD

Role: CONTACT

Phone: +393201437658

Email: [email protected]

Maurizio Zazzi, Prof

Role: CONTACT

Phone: +390577233863

Email: [email protected]

Facility Contacts

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Barbara Rossetti, PhD

Role: primary

Maurizio Zazzi, Prof

Role: backup

Other Identifiers

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2018-004885-32

Identifier Type: -

Identifier Source: org_study_id