Genotyping FcɣRs Genes of HIV-1 Patients "Progressor": Co... | NCT03130296

Studies
Genotyping FcɣRs Genes of HIV-1 Patients "Progressor": Correlation With the Changing Profile of the Infection

NCT03130296

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

May 12, 2017Actual

Enrollment

230Estimated

Phase

Not provided

Conditions

HIV 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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2017Actual

Primary Completion Date

Feb 16, 2020Estimated

Completion Date

Feb 16, 2020Estimated

First Submitted Date

Apr 21, 2017

First Submission Date that Met QC Criteria

Apr 21, 2017

First Posted Date

Apr 26, 2017Actual

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

May 11, 2017

Last Update Posted Date

May 12, 2017Actual

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

This non-interventional study aims to determine whether there is a correlation between the Fc receptor polymorphism (FcR) and the course of the disease following HIV infection.

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

No data available

No data is available for this block.

Enrollment

230Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation research between Fc receptor polymorphism (FcR) and the course of disease following HIV infection.		After infection, up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient aged 18 or older,
Patient affiliated to a social security scheme,
Informed consent dated and signed by the investigating physician the patient,
Patients infected with HIV-1 having progressed in clinical (stage C) or biologically (CD4 nadir <350 / mm3 and viral load> 10,000 copies / ml)

Exclusion Criteria:

Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...)
Subject under safeguard of justice,
Subject under tutelage or under curatorship,

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

Patients infected with HIV-1 having progressed in clinical (stage C) or biologically (CD4 nadir <350 / mm3 and viral load> 10,000 copies / ml)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David REY, MD	Contact	33 3 69 55 05 01		David.Rey@chru-strasbourg.fr
Christiane MOOG, PhD	Contact	33 3 68 85 37 42		c.moog@unistra.fr

Overall Officials

Name	Affiliation	Role
David REY, MD	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Le Trait d'Union - Centre de soins de l'infection par le VIH au NHC	Recruiting	Strasbourg		67091	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided