2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
Status:
Active, not recruiting
Trial end date:
2025-04-30
Target enrollment:
Participant gender:
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 this has an influence on different parameters such as severity of HIV disease
(evaluated by viral load and viral reservoir size), presence of non-AIDS related health
complications, impact the phenotype and function of the immune system.
By conducting this study we want to assess whether switching from 3DR to 2DR implies an
increased risk for 'subclinical' failure. We especially want to make sure that this switch
does not increase the HIV reservoir, does not increase inflammation or immune exhaustion in
patients living with HIV and that it can be considered as a safe long term alternative for
the classic 3DR.
The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato)
regimen compared to BIC/TAF/FTC (Biktarvy) in terms of the amount of intact replication
competent HIV sequences with a non-inferiority margin of 12% quantified by the fraction
intact HIV viral sequences quantified by IPDA, present in blood CD4 cells.