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CompletedNCT01754311HAMIL28BUpdated Mar 21, 2018

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

An observational study in HTLV-I Infections, sponsored by University Hospital Center of Martinique. Completed at 2 sites in Martinique. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-21.

Sponsored by University Hospital Center of Martinique · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
155
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • HTLV-I Infections

Keywords

  • HTLV-I
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 155 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University Hospital Center of Martinique is the lead sponsor of 77 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

HTLV-1 infected patients :

Adult, followed in consultation of Neurology of the University Hospital of Fort-de-France for their HTLV-1 infection.

Blood Donors ; Adult, age 18 to 70 years coming to give their blood in one of building or mobile collection facilities of Martinique French Blood Establishement

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

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
155 participants (actual)
Patient registry
No

Groups and cohorts

  • HTLV-1 infected patients

    HAM/TSP patients and HTLV-1 Asymtomatic patients

  • control

    Blood donors

06

What researchers measure

Primary outcomes

  1. Presence of CT or TT allele for each participant

    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)

    Time frame: 30 days

07

Study locations

2 sites
  • University Hospital of Fort de France
    Fort de France, 97261, Martinique
  • French Blood Establishement
    Fort-de-France, 97264, Martinique
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01754311
Lead sponsor
University Hospital Center of Martinique
Collaborators
Laboratoire Cerba
Responsible party
Sponsor
First posted
Dec 21, 2012
Start date
May 13, 2013
Primary completion
Jun 24, 2014
Completion
Jun 24, 2014
Last update
Mar 21, 2018

Study contacts

Stephane Olindo, MD
principal investigator · University Hospital of Fort de France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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