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

Erasmus University

Status: Active, not recruiting

Conditions: Hiv

Treatments: Drug: Dolutegravir / Lamivudine Pill

Study type: Observational

Funder types: Other

Identifiers

NCT04707326

DUALING

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,040 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

2,040 participants in 4 patient groups

DTG based switchers to DTG/3TC

Description:

HIVRNA suppressed HIV patients who switched to DTG/3TC

DTG based triple drug cART

Description:

Matched HIVRNA suppressed patients who remained on triple drug DTG based cART

non-DTG based switchers to DTG/3TC

Treatment:

Drug: Dolutegravir / Lamivudine Pill

non-DTG based triple drug cART

Description:

Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART