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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06637813
Acronym
NEW_ODOACRE
Enrollment
1220
Registered
2024-10-15
Start date
2024-10-30
Completion date
2034-10-30
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV -1 Infection

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.

Interventions

OTHERBlood sampling for evaluation of biomarkers

Non-routine diagnostic test evaluations

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Establishment of a database10 yearsSystematic 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.

Contacts

Primary ContactSIMONA DI GIAMBENEDETTO, Dr
SIMONA.DIGIAMBENEDETTO@UNICATT.IT+390630155366
Backup ContactFRANCESCA LOMBARDI, DR
FRANCESCA.LOMBARDI@POLICLINICOGEMELLI.IT+390630155366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026