Immune Activation Markers in HIV-infected Patients Switch... | NCT05433987

Studies
Immune Activation Markers in HIV-infected Patients Switching to Long Acting Dual Therapy

NCT05433987

Sponsor

Centre Hospitalier de Cannes Simone Veil

Status

Completed

Last Update Posted

Aug 28, 2024Actual

Enrollment

20Actual

Phase

Not provided

Conditions

HIV-1-infection

Interventions

Not provided

Countries

France

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2022Actual

Primary Completion Date

Nov 17, 2023Actual

Completion Date

Nov 17, 2023Actual

First Submitted Date

Jun 21, 2022

First Submission Date that Met QC Criteria

Jun 24, 2022

First Posted Date

Jun 27, 2022Actual

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

Aug 27, 2024

Last Update Posted Date

Aug 28, 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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cART) to a long acting dual therapy in HIV-infected patients

Detailed Description

Patients meeting the inclusion criteria will be offered to participate to the study.

In case of acceptance by given their writting consent, 6 ml of blood will be collected for measuring immune activation and inflammatory markers, during the blood test scheduled for the routine follow-up.

Six months after cART change, an equal volume of blood will be collected for measuring the same immune activation and inflammatory markers

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

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution the trajectory of immune activation and inflammatory markers	Assess the trajectory of immune activation and inflammatory markers change at 6 month after modifying cART	Baseline and 6 months after modiyfying cART

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of patients with successful cART	To evaluate prevalence of patients with successful cART (i.e. viral load below 50 copies/ml) 1 month after the switch	1 month, 3 month, 6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients agreeing to participate to the study and to collect their data
HIV-1 infected subjects
Patients switching from a stable (at least 6 months) and successful triple cART to a long acting dual cART
Patients older than 18 yrs and regularly followed in Cannes and Nice hospitals
Patients with a healthcare card

Exclusion Criteria:

HIV-2 infected subjects
Patients not being on successful and stable cART
Patients having being treated during acute HIV-infection
Patients modifying cART for virological failure
Subjects modifying their treatment for another combination than from a triple cART to a dual cART
Patients modifying cART during the 6 months of follow-up
Patients refusing to participate to the study
Patients included in an interventional study during the 6 months of follwo-up
Patient under juridical procedure

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

Patient HIV-1, regularly followed in Cannes and Nice Hospital and for which the doctor has decided to modify the treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matteo Vassallo, MD	Centre Hospitalier de Cannes Simone Veil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nathalie DOUX		Cannes		06414	France