- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03130296
Genotyping FcɣRs Genes of HIV-1 Patients "Progressor": Correlation With the Changing Profile of the Infection
May 11, 2017 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
230
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christiane MOOG, PhD
- Phone Number: 33 3 68 85 37 42
- Email: c.moog@unistra.fr
Study Contact Backup
- Name: David REY, MD
- Phone Number: 33 3 69 55 05 01
- Email: David.Rey@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67091
- Recruiting
- Le Trait d'Union - Centre de soins de l'infection par le VIH au NHC
-
Contact:
- Christiane MOOG, PhD
- Phone Number: 33 3 68 85 37 42
- Email: c.moog@unistra.fr
-
Contact:
- David REY, MD
- Phone Number: 33 3 69 55 05 01
- Email: David.Rey@chru-strasbourg.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
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)
Description
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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation research between Fc receptor polymorphism (FcR) and the course of disease following HIV infection.
Time Frame: After infection, up to 12 months
|
After infection, up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David REY, MD, University Hospital, Strasbourg, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2017
Primary Completion (Anticipated)
February 16, 2020
Study Completion (Anticipated)
February 16, 2020
Study Registration Dates
First Submitted
April 21, 2017
First Submitted That Met QC Criteria
April 21, 2017
First Posted (Actual)
April 26, 2017
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- HIV Infections
- Infections
- Communicable Diseases
Other Study ID Numbers
- 6493
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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