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

NCT04155554 | Unknown Phase 3 DMC

• 1 other identifier: 2018-004885-32
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Keywords

HIV; Neurocognitive functions; Neuropsychiatric side effects; Bictegravir; INSTI

Outcome Measures

Primary Outcomes (1)

• neuropsychiatric symptoms severity in 3 months

  change in neuropsychiatric symptoms severity, using the Symptom Checklist-90-R, 3 months after switching to bictegravir or continuing dolutegravir (on treatment analysis).

  3 months

Secondary Outcomes (9)

• neuropsychiatric symptoms severity in 3 and 12 months

  12 months

• Mini International Neuropsychiatric Interview Plus subscale for suicide risk

  12 months

• neurocognitive performance

  12 months

• neurocognitive impairment and neuropsychiatric symptoms

  12 months

• self-reported symptoms (21 items, 0-5 points for each), adherence (0-100%) and HR-QoL (9 items, 0-5 points for each)

  12 months

Study Arms (2)

Bictegravir/emtricitabine/tenofovir alafenamide

EXPERIMENTAL

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

Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Dolutegravir/lamivudine/abacavir

ACTIVE COMPARATOR

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

Drug: Dolutegravir/lamivudine/abacavir

Interventions

Bictegravir/emtricitabine/tenofovir alafenamide DRUG

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

Also known as: Biktarvy

Bictegravir/emtricitabine/tenofovir alafenamide

Dolutegravir/lamivudine/abacavir DRUG

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

Also known as: Triumeq

Dolutegravir/lamivudine/abacavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese: lead
• Catholic University of the Sacred Heart: collaborator
• Ospedale Policlinico San Martino: collaborator
• Azienda Ospedaliera San Paolo: collaborator
• Ospedale Amedeo di Savoia: collaborator

Study Sites (1)

Barbara Rossetti

Siena, 53100, Italy

RECRUITING

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; abacavir, dolutegravir, and lamivudine drug combination

Study Officials

• Barbara Rossetti, PhD

  Azienda Ospedaliera Universitaria Senese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Rossetti, PhD

CONTACT

+393201437658; barbara.rossetti@ao-siena.toscana.it

Maurizio Zazzi, Prof

CONTACT

+390577233863; maurizio.zazzi@unisi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: January 29, 2020
• Primary Completion: August 1, 2020
• Study Completion: July 1, 2021
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)