Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Erasmus Medical Center
- Enrollment
- 2,040
- Locations
- 9
- Primary Endpoint
- Efficacy On Treatment (OT)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
non-DTG based switchers to DTG/3TC
Intervention: Dolutegravir / Lamivudine Pill (Drug)
Outcomes
Primary Outcomes
Efficacy On Treatment (OT)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Casper Rokx
MD PhD
Erasmus Medical Center