HTLV-I Clinical Trial
Official title:
Natural History of HTVL-I: A Cross-Sectional Study of a Cohort of Blood Donors in Jamaica
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.
Southern Japan and the Caribbean are both endemic for human T-lymphotropic virus type I
(HTLV-I) infection. In these areas, however, epidemiology of HTLV-I appears to differ.
Various observations from population-based studies indicate that differences in host immune
response to virus infection is likely to result in different frequencies of disease
manifestations across geographic regions. While gender, age and route of infection may partly
determine host immune response, the observed geographic differences may also reflect, in
part, host genetic background as evidenced by the distribution of human leukocyte antigens
(HLA) and presence of other environmental factors.
The reported differences underscore the need for comparative studies in these endemic areas.
In addition, analyses of larger, pooled data of HTLV-I carriers from different geographic
areas are needed to ensure statistical power in studies of gene-environment interactions with
extended use of molecular markers. However, existing population-based studies from Japan and
the Caribbean are unfortunately no comparable with respect to the study subject's age and
gender distributions. In order to address this issue, we proposed a study of blood donors in
Jamaica, which enrolls a large number of both HTLV-I positive and HTLV-I negative, consisting
of subjects that are more comparable to existing Japanese study with respect to age and sex.
The proposed study will provide a basis for a comparative study of HTLV-I carriers in Japan
and Jamaica and a comprehensive analysis of host genetic background of HTLV-I associated
illnesses in the Black population.
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