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

Active, not recruiting

• Conditions: Hiv
• Interventions: Drug: Dolutegravir / Lamivudine Pill

• Registration Number: NCT04707326
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Primary Completion: 2023-11-01
• Results First Submitted: 2024-07-16
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Results First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2040

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-DTG based switchers to DTG/3TC	Dolutegravir / Lamivudine Pill	-

Primary Outcome Measures

Name	Time	Method
Efficacy On Treatment (OT)	1 year	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
Efficacy Intention to Treat (ITT)	1 year	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.

Trial Locations

Locations (9)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Admiraal de Ruyter Ziekenhuis; 🇳🇱 Goes, Netherlands

Spaarne Gasthuis; 🇳🇱 Haarlem, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

MC Haaglanden; 🇳🇱 Rotterdam, Netherlands

Maasstad Hospital; 🇳🇱 Rotterdam, Netherlands

Elisabeth Tweesteden Hospital; 🇳🇱 Tilburg, Netherlands