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Not yet recruiting NCT06637813

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

Observational HIV -1 Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sampling for evaluation of biomarkers.
Who it may be relevant to
Registry conditions: HIV -1 Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

Interventions

  • Other Blood sampling for evaluation of biomarkers
    Non-routine diagnostic test evaluations

Primary outcome measures

  • Establishment of a database [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06637813 · 7059

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗