Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1 (HAMIL28B)
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|ClinicalTrials.gov Identifier: NCT01754311|
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : March 21, 2018
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 or disease|
|Study Type :||Observational|
|Actual Enrollment :||155 participants|
|Official Title:||Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1|
|Actual Study Start Date :||May 13, 2013|
|Actual Primary Completion Date :||June 24, 2014|
|Actual Study Completion Date :||June 24, 2014|
HTLV-1 infected patients
HAM/TSP patients and HTLV-1 Asymtomatic patients
- Presence of CT or TT allele for each participant [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754311
|University Hospital of Fort de France|
|Fort de France, Martinique, 97261|
|French Blood Establishement|
|Fort-de-France, Martinique, 97264|
|Principal Investigator:||Stephane Olindo, MD||University Hospital of Fort de France|