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Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1 (HAMIL28B)

This study is not yet open for participant recruitment.
Verified December 2012 by Centre Hospitalier Universitaire de Fort-de-France
Sponsor:
Collaborator:
Laboratoire Cerba
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01754311
First received: December 14, 2012
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

Only 5 to 10% of patients infected with HTLV-1 develop a disease related to infection. The two most serious diseases are adult T-cell leukemia (ATL) and Tropical spastic paraparesis /HTLV-I-associated myelopathy (TSP / HAM). Factors influencing the development of TSP / HAM in the individual HTLV-1 are not yet completely understood. Patients TSP / HAM have a HTLV-1 proviral load (amount of virus) that is 6-10 times higher than seropositive asymptomatic.

Various studies have shown that the development of TSP / HAM in the subject HTLV-1 and its rapid evolution is partly attributed to the failure of the immune system that regulates viral replication and expression.

It has recently been shown that different versions of Single Nucleotide (human leukocyte antigen) rs12979860, located upstream of the gene for Interleukin 28B (IL28B), influenced the severity of infection with hepatitis C and effectiveness of treatment.

By analogy with hepatitis C, a Spanish (Treviño et al., 2012) examined this SNP(single nucleotide polymorphism) in 12 patients TSP / HAM and 29 asymptomatic HIV-positive. CT or TT genotype was statistically more frequent in the group TSP / HAM than in asymptomatic patients (80% versus 20%) and was associated with HTLV-1 proviral load higher.

We propose a broader group of patients in our population and Afro-Caribbean, to confirm the results of the latter study was conducted in a predominantly Latin American population.


Condition
HTLV-I Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:

Primary Outcome Measures:
  • Presence of CT or TT allele for each participant [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    The participants will be followed until the end of the study ( with an expected average of 30 days after the inclusion).

    Explenations : each participant will have a blood sample who will be performed at the recruitement day (for génetics analysis) . After this first visit (recuitement visit) , each participant will have to perform an appointement with the ophtalmologic département ( recuperate datas about the presence or not of an uveitis and a keratoconjunctivitis)



Estimated Enrollment: 165
Study Start Date: February 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HTLV-1 infected patients
HAM/TSP patients and HTLV-1 Asymtomatic patients
control
Blood donors

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HTLV-1 infected patients :

Adult, followed in consultation of Neurology of the University Hospital of Fort-de-France for their HTLV-1 infection.

Blood Donors ; Adult, age 18 to 70 years coming to give their blood in one of building or mobile collection facilities of Martinique French Blood Establishement

Criteria

Inclusion Criteria :

HAM/TSP Patient:

  • Age over 18 years
  • Whose HAM/TSP was diagnosed on the criteria of Belem (De Castro-Costa et al., 2006)
  • Follow regular consultation of Neurology of the University Hospital of Fort-de-France,
  • Affiliate a system of social security (or entitled Beneficiary)
  • Having agreed to participate in research by signing the consent form.

HTLV-1 asymptomatic patient:

  • Age over 18 years
  • Follow regular consultation of Neurology of the University Hospital of Fort-de-France,
  • Do not show clinical signs of neurological impairment (a pyramidal syndrome with functional impairment clinic, genito-sphincter, motor deficits suggestive of polymyositis belts)
  • Affiliate a system of social security (or entitled Beneficiary)
  • Having agreed to participate in research by signing the consent form.

Blood donors:

  • Respecting the eligibility criteria for blood donation
  • Affiliated with the social security system (or entitled Beneficiary)
  • Having agreed to participate in research by signing the consent form
  • Serology HTLV-1 negative at the time of blood donation

Exclusion Criteria :

HAM/TSP Patient:

  • Featuring an intricate polypathology may cast doubt on the responsibility of HTLV-1 in neurological symptoms,
  • Infected with HIV or HBV or HCV
  • Not affiliated to a social security (or entitled beneficiary)
  • Do not sign the form for obtaining consent.

HTLV-1 asymptomatic patient:

  • Infected with HIV or HBV or HCV
  • Not affiliated to a social security (or entitled beneficiary)
  • Do not sign the form obtaining informed consent.

Blood donors:

  • Do not meet the eligibility criteria for blood donation
  • Not affiliated to a social security (or entitled beneficiary)
  • Do not sign the form obtaining informed consent
  • Serology HTLV-1 positive or doubtful
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754311

Contacts
Contact: Janick Jean-Marie, Master (0)596592697 ext 596 janick.jean-marie@chu-defortdefrance.fr

Locations
Martinique
University Hospital of Fort de France Not yet recruiting
Fort de France, Martinique, 97261
Contact: Stephane Olindo, MD     (0)596 55 22 61 ext 596     stephane.olindo@chu-fortdefrance.fr    
Principal Investigator: Stephane Olindo, MD            
French Blood Establishement Not yet recruiting
Fort-de-France, Martinique, 97264
Contact: Pascale RICHARD, MD     (0)596 75 79 15 ext 596     pascale.richard@efs.sante.fr    
Principal Investigator: Pascale Richard, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Fort-de-France
Laboratoire Cerba
Investigators
Principal Investigator: Stephane Olindo, MD University Hospital of Fort de France
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier: NCT01754311     History of Changes
Other Study ID Numbers: 13/B/01
Study First Received: December 14, 2012
Last Updated: December 18, 2012
Health Authority: France : National Safety Agency of drug and Health Products

Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:
HTLV-I

Additional relevant MeSH terms:
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013