Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1 (NCT01754311) | Clinical Trial Compass
CompletedNot Applicable
Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1
Martinique155 participantsStarted 2013-05-13
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 securi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.