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Clinical Trials/NCT06637813
NCT06637813
Not yet recruiting
Not Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 sites1,220 target enrollmentOctober 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV -1 Infection
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
1220
Primary Endpoint
Establishment of a database
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 30, 2024
End Date
October 30, 2034
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Time Frame: 10 years

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.

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