Establishment of a Database of HIV Subjects Initiating or... | NCT06637813

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

NCT06637813

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Not yet recruiting

Last Update Posted

Oct 15, 2024Actual

Enrollment

1,220Estimated

Phase

Not provided

Conditions

HIV -1 Infection

Interventions

Blood sampling for evaluation of biomarkers

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2024Estimated

Primary Completion Date

Oct 30, 2025Estimated

Completion Date

Oct 30, 2034Estimated

First Submitted Date

Oct 9, 2024

First Submission Date that Met QC Criteria

Oct 9, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2024

Last Update Posted Date

Oct 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,220Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling for evaluation of biomarkers	Other	Non-routine diagnostic test evaluations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Establishment of a database	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.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HIV subjects treated with Dovato from 2015 to 2022. (retrospective cohort) or who will start treatment from clinical practice with Dovato

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
SIMONA DI GIAMBENEDETTO, Dr	Contact	+390630155366		SIMONA.DIGIAMBENEDETTO@UNICATT.IT
FRANCESCA LOMBARDI, DR	Contact	+390630155366		FRANCESCA.LOMBARDI@POLICLINICOGEMELLI.IT

Overall Officials

Name	Affiliation	Role
Simona Di Giambenedetto	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided