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

Completed

• Conditions: HTLV-I Infections

• Registration Number: NCT01754311
• Lead Sponsor: University Hospital Center of Martinique

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Study Start: 2013-05-13
• Primary Completion: 2014-06-24
• Study Completion: 2014-06-24
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of CT or TT allele for each participant	30 days	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)

Trial Locations

Locations (2)

French Blood Establishement; 🇲🇶 Fort-de-France, Martinique

University Hospital of Fort de France; 🇲🇶 Fort de France, Martinique