NCT03130296

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2020

Completed
Last Updated

May 12, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

April 21, 2017

Last Update Submit

May 11, 2017

Conditions

HIV Infection

Keywords

HIV infectionFc receptor polymorphism (FcR)

Outcome Measures

Primary Outcomes (1)

  • Correlation research between Fc receptor polymorphism (FcR) and the course of disease following HIV infection.

    After infection, up to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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)

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Trait d'Union - Centre de soins de l'infection par le VIH au NHC

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • David REY, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David REY, MD

CONTACT

33 3 69 55 05 01David.Rey@chru-strasbourg.fr

Christiane MOOG, PhD

CONTACT

33 3 68 85 37 42c.moog@unistra.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2017

First Posted

April 26, 2017

Study Start

February 16, 2017

Primary Completion

February 16, 2020

Study Completion

February 16, 2020

Last Updated

May 12, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)