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

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.

Study Overview

• Status: Completed
• Conditions: HTLV-I Infections

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Martinique
  • Fort de France, Martinique, 97261
    • University Hospital of Fort de France
  • Fort-de-France, Martinique, 97264
    • French Blood Establishement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HTLV-1 infected patients; HAM/TSP patients and HTLV-1 Asymtomatic patients
control; Blood donors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of CT or TT allele for each participant	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)	30 days

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Collaborators: Laboratoire Cerba
• Investigators: Principal Investigator: Stephane Olindo, MD, University Hospital of Fort de France

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2013
• Primary Completion (Actual): June 24, 2014
• Study Completion (Actual): June 24, 2014

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 21, 2012

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: HTLV-I
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Deltaretrovirus Infections; Infections; Communicable Diseases; HTLV-I Infections
• Other Study ID Numbers: 13/B/01