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

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 Overview

• Status: Not yet recruiting
• Conditions: HIV -1 Infection
• Intervention / Treatment: Other: Blood sampling for evaluation of biomarkers

• Study Type: Observational
• Enrollment (Estimated): 1220

Contacts and Locations

• Study Contact: Name: SIMONA DI GIAMBENEDETTO, Dr; Phone Number: +390630155366; Email: SIMONA.DIGIAMBENEDETTO@UNICATT.IT
• Study Contact Backup: Name: FRANCESCA LOMBARDI, DR; Phone Number: +390630155366; Email: FRANCESCA.LOMBARDI@POLICLINICOGEMELLI.IT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HIV subjects treated with Dovato from 2015 to 2022. (retrospective cohort) or who will start treatment from clinical practice with Dovato

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Simona Di Giambenedetto, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2034

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 7059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No