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

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ClinicalTrials.gov Identifier: NCT03130296
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease
HIV Infection

Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genotyping FcɣRs Genes of HIV-1 Patients "Progressor": Correlation With the Changing Profile of the Infection
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : February 16, 2020
Estimated Study Completion Date : February 16, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Correlation research between Fc receptor polymorphism (FcR) and the course of disease following HIV infection. [ Time Frame: After infection, up to 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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)
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130296


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

Locations
France
Le Trait d'Union - Centre de soins de l'infection par le VIH au NHC Recruiting
Strasbourg, France, 67091
Contact: David REY, MD    33 3 69 55 05 01    David.Rey@chru-strasbourg.fr   
Contact: Christiane MOOG, PhD    33 3 68 85 37 42    c.moog@unistra.fr   
Sub-Investigator: Maria Partisani, MD         
Sub-Investigator: Christine Cheneau, MD         
Sub-Investigator: Michele Priester, MD         
Sub-Investigator: Marie Laure Batard, MD         
Sub-Investigator: Claudine Bernard-Henry, MD         
Sub-Investigator: Christiane Moog, PhD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: David REY, MD University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03130296     History of Changes
Other Study ID Numbers: 6493
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Strasbourg, France:
HIV infection
Fc receptor polymorphism (FcR)

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases