HTLV-I InfectionsHAMIL28BNCT01754311
Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1
An observational study of HTLV-I Infections, run by University Hospital Center of Martinique at 2 sites in Martinique.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HTLV-I Infections
- How many people
- 155 participants
- Where
- 2 sitesMartinique
- Study dates
- 13 May 2013to 24 Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
2 sites in 1 country.
Martinique2 sites
University Hospital of Fort de France
Fort-de-France, 97261
French Blood Establishement
Fort-de-France, 97264
About this study
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.
Read more
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.
- Conditions
- HTLV-I Infections
- Keywords
- HTLV-I
- Medical subject headings
- HTLV-I Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HTLV-1 infected patients | HAM/TSP patients and HTLV-1 Asymtomatic patients | |
| control | Blood donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study start13 May 2013
- Primary completion24 Jun 2014
- Study completion24 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HTLV-I InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Cerba
- Responsible party
- Sponsor
- Investigators
- Stephane Olindo, MD, Principal investigator, University Hospital of Fort de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754311
- Sponsor's protocol ID
- 13/B/01
- Acronym
- HAMIL28B
- Status last verified
- Mar 2018
- First submitted
- 14 Dec 2012
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1
- ClinicalTrials.gov ID
- NCT01754311
- Acronym / sponsor ID
- HAMIL28B / 13/B/01
- Conditions
- HTLV-I Infections
- Keywords
- HTLV-I
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Laboratoire Cerba
- Study start
- 13 May 2013 (actual)
- Primary completion
- 24 Jun 2014 (actual)
- Study completion
- 24 Jun 2014 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTLV-1 infected patients | – | –HAM/TSP patients and HTLV-1 Asymtomatic patients |
| control | – | –Blood donors |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- Infected with HIV or HBV or HCV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
Related trials for HTLV-I Infections
RecruitingObservational study
Evaluation of Patients With HAM/TSP
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Acute Adult T-Cell Leukemia/Lymphoma, Adult T-Cell Leukemia/Lymphoma
RecruitingPhase 2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
HTLV-1 Infection, HTLV I Associated Myelopathies
Active, not recruitingObservational study
Clinico-biological Characterization and Survival of Patients With Adult T-cell Leukemia / Lymphoma (ATL) and Patients Chronically Infected With the HTLV-1 Virus (HTLV-OBS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane Olindo, MD principal investigator
University Hospital of Fort de France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HTLV-I Infections, run by University Hospital Center of Martinique at 2 sites in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of CT or TT allele for each participant (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.