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NCT01754311: HAMIL28B

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

Completed Last updated 21 March 2018
What this trial tests

trial in HTLV-I Infections in 155 participants. Completed in 24 June 2014.

Timeline
13 May 2013
Primary endpoint
24 June 2014
24 June 2014

Quick facts

Lead sponsorUniversity Hospital Center of Martinique
StatusCompleted
Study typeOBSERVATIONAL
Enrollment155
Start date13 May 2013
Primary completion24 June 2014
Estimated completion24 June 2014
Sites2 locations across Martinique

Conditions studied

Sponsor

University Hospital Center of Martinique

Who can join

Adults 18 to 70, any sex, with HTLV-I Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Oncoprotein Fra-2 Drives the Activation of Human Endogenous Retrovirus Env Expression in Adult T-Cell Leukemia/Lymphoma (ATLL) Patients.
    Tram J, Marty L, Mourouvin C, Abrantes M, et al · · 2024 · PMID 39329701 · DOI 10.3390/cells13181517

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