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NCT Number: NCT01754311

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

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.

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Key information

Conditions

HTLV-I Infections Deltaretrovirus Infections Immune System Diseases Immunologic Deficiency Syndromes Infections RNA Virus Infections Retroviridae Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

French Blood Establishement, Fort-de-France, Martinique

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Collaborators

  • Laboratoire Cerba

Registry information

Acronym: HAMIL28B

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2012
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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