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Retrovirus Epidemiology Donor Study (REDS) HTLV Cohort

Clinical Trials URL: http://clinicaltrials.gov/ct2/show/...
Study Type: Epidemiology Study
Prepared on October 13, 2008
Last Updated on January 24, 2008
Study Dates: 1989-2007
Consent: Unrestricted Consent
Commercial Use Restrictions: No
NHLBI Division: DBDR
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information

Objectives

To conduct a longitudinal, multicenter epidemiologic study of the human retroviruses HIV-1, HIV-2, HTLV-I, and HTLV-II in volunteer blood donors from areas of the United States that were reportedly at high and medium or low risk for HIV.

Background

Previous evidence suggested that human T-lymphotropic virus type II (HTLV-II) infection is associated with an increased incidence of bacterial infections.

Subjects

The study includes 154 HTLV-I infected, 387 HTLV-II infected and 799 uninfected blood donors, all of whom were HIV type 1 seronegative at enrollment. Of the 1340 present and former blood donors examined at enrollment, 1213 (90.5%) were re-examined after approximately 2 years, including 136 HTLV-I and 337 HTLV-II seropositive subjects and 740 demographically stratified HTLV-seronegative subjects.

Conclusions

The data support an increased incidence of infectious diseases among otherwise healthy HTLV-II and HTLV-I infected subjects. They are also consistent with the lymphoproliferative effects of HTLV-I, and with neuropathic effects of HTLV-I and HTLV-II. (Arch Intern Med. 1999;159:1485-1491)


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