HTLV-I Clinical Trial
Official title:
Natural History of HTVL-I: A Cross-Sectional Study of a Cohort of Blood Donors in Jamaica
Verified date | August 11, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Human T-lymphotrophic virus type I (HTLV-I) is endemic in southern Japan and the Caribbean,
but disease manifestations differ across geographic regions. Though age, gender, and route of
infection may determine the natural history of this infection, the observed geographic
differences also may, in part, reflect the distinct genetic background of the host as
evidenced by the distribution of human leukocyte antigens (HLA) and the presence of other
environmental factors.
Studies already completed or ongoing have shown notable differences in incidence and
prevalence of HTLV-I associated diseases and underscore the need for comparative studies and
analyses in these areas. This prospective new study of blood donors in Jamaica provides us
with an opportunity to address many hypotheses regarding HTLV-I transmission and pathogenesis
in the Caribbean in comparison with an ongoing cohort study of HTLV-I carriers in Japan.
This study will
- identify host factors associated with HTLV-I carrier status and HTLV-I pathogenesis.
- directly calculate the incidence of HTLV-I associated diseases in this population.
- examine the role of HTLV-I in the pathogenesis of other common infectious agents.
Approximately 5,000+ blood donors who came to the National Blood Transfusion each year will
be screened for HTLV-I serology. Of those who agreed to participate, all HTLV-I carriers and
age-, and sex-matched HTLV-I-negatives will be invited to the University of the West Indies
clinic for a full study enrollment. Study participants will be given a standardized
questionnaire, a full physical examination, and a phlebotomy (25-30 mL), and will be followed
every other year for interim health status and additional phlebotomy. All subjects will
receive an ophthalmologic examination for detection of uveitis and other ocular diseases.
Some subjects will be further referred to a neurologist, hematologist or dermatologist,
according to their signs and symptoms. Approximately 1200 HTLV-I carriers and 600 HTLV-I
negatives will be recruited for a longitudinal follow-up over the next 5-year period. Two
types of analyses will be conducted: comparison of HTLV-I-positive and HTLV-I-negative
subjects, and comparison among HTLV carriers between those with a high level of viral load
and those with a low level.
Status | Completed |
Enrollment | 1500 |
Est. completion date | August 11, 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: Healthy blood donors in Kingston, Jamaica. All HTLV-I positive donors and age-, sex-matched HTLV-1 negative donors (controls) will be enrolled. |
Country | Name | City | State |
---|---|---|---|
Jamaica | University of the West Indies | Kingston |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
Jamaica,
Hinuma Y, Nagata K, Hanaoka M, Nakai M, Matsumoto T, Kinoshita KI, Shirakawa S, Miyoshi I. Adult T-cell leukemia: antigen in an ATL cell line and detection of antibodies to the antigen in human sera. Proc Natl Acad Sci U S A. 1981 Oct;78(10):6476-80. — View Citation
Madeleine MM, Wiktor SZ, Goedert JJ, Manns A, Levine PH, Biggar RJ, Blattner WA. HTLV-I and HTLV-II world-wide distribution: reanalysis of 4,832 immunoblot results. Int J Cancer. 1993 May 8;54(2):255-60. — View Citation
Poiesz BJ, Ruscetti FW, Gazdar AF, Bunn PA, Minna JD, Gallo RC. Detection and isolation of type C retrovirus particles from fresh and cultured lymphocytes of a patient with cutaneous T-cell lymphoma. Proc Natl Acad Sci U S A. 1980 Dec;77(12):7415-9. — View Citation
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