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