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.
Name: Dual versus triple therapy in treatment of HIV-1 infection.
Description: The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in HIV-1 infected individuals in terms of the amount of intact replication-competent HIV-1 sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by IPDA, present in blood CD4 cells.
Measure: Virological control Time: 48 weeksAllocation: Randomized
Parallel Assignment
There is one SNP
- Treatment failure on an integrase inhibitor containing regimen and reported baseline resistance - Creatinine Clearance <50 - Tuberculosis treatment - Documented M184V - Previous virological failure >200 copies/mL on NRTI - Subjects with history or presence of allergy to any of the study drugs or their components - ALT >5 times the ULN, OR ALT >3xULN and bilirubin >1.5xULN (with >35% direct bilirubin) Inclusion Criteria: - Age = or >18 years. --- M184V ---
- Treatment failure on an integrase inhibitor containing regimen and reported baseline resistance - Creatinine Clearance <50 - Tuberculosis treatment - Documented M184V - Previous virological failure >200 copies/mL on NRTI - Subjects with history or presence of allergy to any of the study drugs or their components - ALT >5 times the ULN, OR ALT >3xULN and bilirubin >1.5xULN (with >35% direct bilirubin) HIV-1-infection null --- M184V ---