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

NCT ID: NCT06637813

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-30

Study Completion Date

2034-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV -1 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Blood sampling for evaluation of biomarkers

Non-routine diagnostic test evaluations

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simona Di Giambenedetto

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Central Contacts

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SIMONA DI GIAMBENEDETTO, Dr

Role: CONTACT

+390630155366

FRANCESCA LOMBARDI, DR

Role: CONTACT

+390630155366

Other Identifiers

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7059

Identifier Type: -

Identifier Source: org_study_id

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