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NCT Number: NCT06637813

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

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.

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Key information

Conditions

HIV -1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling for evaluation of biomarkers

Other

Non-routine diagnostic test evaluations

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

FRANCESCA LOMBARDI, DR

CONTACT

[email protected]

+390630155366

SIMONA DI GIAMBENEDETTO, Dr

CONTACT

[email protected]

+390630155366

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: NEW_ODOACRE

Important dates

Study start
2024
Primary completion
2025
Study completion
2034
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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