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

NCT04155554 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-31

No results posted yet for this study

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

Interventions

DRUG

Bictegravir/emtricitabine/tenofovir alafenamide

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

DRUG

Dolutegravir/lamivudine/abacavir

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

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Ospedale Policlinico San Martino

    collaborator OTHER

  • Azienda Ospedaliera San Paolo

    collaborator OTHER

  • Ospedale Amedeo di Savoia

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Senese

    lead OTHER

Principal Investigators

  • Barbara Rossetti, PhD · Azienda Ospedaliera Universitaria Senese

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2020-08-31
Completion
2021-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04155554 on ClinicalTrials.gov