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

HTLV-I Infections Clinical Trial

— HAMIL28B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754311
• Other study ID #: 13/B/01
• Status: Completed
• First received: December 14, 2012
• Last updated: March 19, 2018
• Start date: May 13, 2013
• Est. completion date: June 24, 2014

Study information

• Verified date: March 2018
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: June 24, 2014
• Est. primary completion date: June 24, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HTLV-I Infections
• Infection

Locations

Country	Name	City	State
Martinique	University Hospital of Fort de France	Fort de France
Martinique	French Blood Establishement	Fort-de-France

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Center of Martinique	Laboratoire Cerba

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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