Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study

N/AActive Not RecruitingNCT04707326

Erasmus Medical Center2,040 enrolled

Overview

This study aims to determine real-life clinical efficacy of virally suppressed patienst switching to DTG/3TC compared to DTG triple drug cART controls

Dolutegravir (DTG) based dual antiretroviral therapy constitutes a paradigm shift from triple drug based therapy. Data outside clinical trials are scarce. This study evaluates the value of DTG/3TC in real life.

Study Type

OBSERVATIONAL

Enrollment

2,040

Conditions

Hiv

Interventions

Dolutegravir / Lamivudine PillDRUG

HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Plasma HIVRNA \<50c/mL on triple drug cART regimen including 2NRTI In care in a HIV treatment center in the Netherlands Consented to ATHENA participation Exclusion Criteria: Documented mutations associated with 3TC or DTG resistance of at least low level Documented inadherence by the treating physician or HepB coinfection (cases only)

Locations (9)

Rijnstate Hospital

Arnhem, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

Admiraal de Ruyter Ziekenhuis

Goes, Netherlands

Outcomes

Primary Outcomes

Efficacy On Treatment (OT)

Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the on treatment population

Time frame: 1 year

Efficacy Intention to Treat (ITT)

Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the intention to treat population.

Time frame: 1 year

Data from ClinicalTrials.gov

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