Natural History of HTLV-I Infection: Prospective Follow-up of a Cohort of Blood Donors in Jamaica

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00339807
First received: June 19, 2006
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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.


Condition
HTLV-I

Study Type: Observational
Official Title: Natural History of HTVL-I: A Cross-Sectional Study of a Cohort of Blood Donors in Jamaica

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1500
Study Start Date: January 2002
Estimated Study Completion Date: August 2011
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339807

Locations
Jamaica
University of the West Indies
Kingston, Jamaica
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00339807     History of Changes
Obsolete Identifiers: NCT00544661
Other Study ID Numbers: 999902112, 02-C-N112
Study First Received: June 19, 2006
Last Updated: August 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Retrovirus
Caribbean
Transmission
Genetic
Viral Markers
HTLV-1

Additional relevant MeSH terms:
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014