Status:

RECRUITING

2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial

Lead Sponsor:

University Hospital, Ghent

Collaborating Sponsors:

ViiV Healthcare

Conditions:

HIV-1-infection

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR). We aim to monitor whether th...

Detailed Description

In HIV care we have been facing a paradigm change over the last years, reaching an ultimatum with the reimbursement of a 2DR regimen both in naïve as in switch patients. The rationale behind dual the...

Eligibility Criteria

Inclusion Criteria:

  • Age = or >18 years.
  • Ability and willingness to provide written informed consent.
  • Ability to attend the complete schedule of assessments and patient visits.
  • Ability and willingness to have blood samples collected and stored indefinitely and used for various research purposes.
  • HIV RNA < 50 copies/mL for at least 3 months on a 2nd generation INSTI based regimen.
  • Females of childbearing potential should be on effective contraception

Exclusion Criteria:

  • Current presence of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification).
  • Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (seroconversion= HBV antigen or viral load negative and positive HBV surface antibody).
  • Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry.
  • Pregnancy or breastfeeding.
  • Patients unable to understand the study protocol or any other condition that in the investigator's opinion may compromise compliance with the study protocol
  • Decompensated liver cirrhosis (Child-Pugh B/C)
  • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones)
  • Psychiatric and psychological disorders, which in the opinion of the investigator, will interfere with the trial conduct or safety of the participant.
  • Previous participation in a trial evaluating an immune modulating agent.
  • Active drug or alcohol use/addiction such that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Treatment failure on an integrase inhibitor containing regimen and reported baseline resistance
  • Creatinine Clearance <50
  • Tuberculosis treatment
  • Documented M184V
  • Previous virological failure >200 copies/mL on NRTI
  • Subjects with history or presence of allergy to any of the study drugs or their components
  • ALT >5 times the ULN, OR ALT >3xULN and bilirubin >1.5xULN (with >35% direct bilirubin)

Key Trial Info

Start Date :

May 26 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2027

Estimated Enrollment :

134 Patients enrolled

Trial Details

Trial ID

NCT04553081

Start Date

May 26 2020

End Date

April 30 2027

Last Update

February 28 2024

Active Locations (1)

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1

Ghent University Hospital

Ghent, Belgium, 9000