Establishment of a Database of HIV Subjects Initiating or Simplifying Dual Therapy With Dolutegravir/Lamivudine

N/ANot Yet RecruitingNCT06637813

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1,220 enrolled

Overview

The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease. The availability of different classes of antiretroviral drugs, such as nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.

Study Type

OBSERVATIONAL

Enrollment

1,220

Conditions

HIV -1 Infection

Interventions

Blood sampling for evaluation of biomarkersOTHER

Non-routine diagnostic test evaluations

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * signed informed consent * patients treated with triple therapy who simplify to 3TC+DTG * patients treatment-naive who start a dual therapy with 3TC+DTG from clinical practice Exclusion Criteria: * lack of willingness to provide informed consent

Outcomes

Primary Outcomes

Establishment of a database

Systematic and continuous collection of data related to clinical, laboratory and treatment characteristics of patients who simplify from triple standard ART or who continue dual therapy with 3TC+DTG, or treatment-naive patients who start the dual regimen with 3TC+DTG. The data will be useful for the evaluation of diagnostic and multiparametric algorithms.

Time frame: 10 years