Analysis of the Persistence, Reservoir and HIV Latency | NCT05752318

Studies
Analysis of the Persistence, Reservoir and HIV Latency

NCT05752318

Sponsor

University Hospital, Strasbourg, France

Status

Not yet recruiting

Last Update Posted

Mar 2, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

HIV Infected Individuals
Informed Consent

Interventions

Not provided

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

Jan 2023

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

Feb 27, 2023Estimated

Primary Completion Date

Jan 25, 2027Estimated

Completion Date

Feb 25, 2027Estimated

First Submitted Date

Jan 12, 2023

First Submission Date that Met QC Criteria

Feb 28, 2023

First Posted Date

Mar 2, 2023Actual

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

Feb 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 APRIL study aims at analyzing HIV reservoirs, latency and persistence on antiretroviral therapy. It enrolls HIV-infected adults providing blood samples of which peripheral blood mononuclear cells are stored. The frequency, phenotype and inducibility of HIV-infected cells are then analyzed. These parameters may vary across the different clinical and therapeutic settings.

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

500Estimated

Measure	Description	Time Frame
HIV-Flow		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-infection
Adults (>18 years)
Social insurance
Informed consent

Exclusion Criteria:

HIV-uninfected
<18 years
Lack of social insurance
Lack or withdraw of consent

Accepts Healthy Volunteers

Not provided

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-infected adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pierre GANTNER, MCU-PH	Contact	03 69 55 16 32		pierre.gantner@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Not provided