Strategies to Contain HIV Drug-Resistance Emergence in Virologically Suppressed Patients Requiring Antiretroviral Therapy Optimization: Unraveling the Role of Mutational Burden in PBMCs (OPTIMA)

Objectives: The main aim of this proposal is to evaluate the impact of drug-resistance burden detected in proviral DNA through Next Generation Sequencing (NGS) on predicting virological outcome in virologically suppressed patients switching therapy. The following secondary objectives will be pursued: - Evaluating the rate and trends of drug-resistance in proviral DNA over time in virologically suppressed patients. - Defining clinically relevant cut-offs to predict virological rebound according to the archived drug-resistance burden in proviral DNA. - Evaluating virological factors (other than archived drug-resistance mutations) correlated with virological rebound. Particular attention will be dedicated to the correlation of HIV-1 DNA burden with the risk of virological failure and drug-resistance emergence. - Characterizing the profiles of drug-resistance mutations emerged at virological rebound.