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

NCT06637813 | Not Yet Recruiting

• 1 other identifier: 7059
• Study Type: observational
• Target: 1,220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV -1 Infection

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Blood sampling for evaluation of biomarkers OTHER

Non-routine diagnostic test evaluations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• lack of willingness to provide informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Biospecimen

Retention: SAMPLES WITH DNA

whole blood biospecimen

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Simona Di Giambenedetto

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SIMONA DI GIAMBENEDETTO, Dr

CONTACT

+390630155366; SIMONA.DIGIAMBENEDETTO@UNICATT.IT

FRANCESCA LOMBARDI, DR

CONTACT

+390630155366; FRANCESCA.LOMBARDI@POLICLINICOGEMELLI.IT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 30, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2034
• Last Updated: October 15, 2024

Record last verified: 2024-10