Clinical Trial: Retrovirus Epidemiology Donor Study I (REDS I)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title:

Brief Summary: To conduct a 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. Also, to determine the prevalence of retrovirus seropositivity in first time blood donors; and the rate of retrovirus seroconversion in repeat blood donors as a measure of incidence of infection; to ascertain risk factors for antibody-positive donors; to characterize the blood donor population by geographic location, age, sex, race/ethnicity, and donation history to permit analysis on prevalence, incidence, and risk factors; to identify recipients of retrovirus-positive blood units and conduct clinical and laboratory follow-up of these recipients; and to establish a blood specimen repository for long-term storage of specimens from study donors and recipients for future testing.

Detailed Summary:

BACKGROUND:

HIV is known to be transmissible by blood, blood components, or plasma derivatives. The risk of contracting HIV infection from blood transfusion has been greatly reduced in the United States by implementing stringent criteria for donor acceptance, HIV antibody screening, and new methods of virus inactivation in coagulation factor concentrates. There are additional human retroviruses, however, that may pose a threat to the safety of the nation's blood supply.

The human T-cell lymphotropic retroviruses share many properties, including a preferred tropism for certain lymphocytes and similar modes of transmission. They also differ significantly from each other and on this basis are divided into two distinct groups: the human T-cell lymphocytropic viruses (HTLVs) and the human immunodeficiency viruses (HIVs). HTLV-I, a transforming virus, is the prototype of the first group (HTLVs). It is associated with adult T-cell leukemia (ATL) and is thought to be involved in a central nervous system disorder referred to as tropical spastic paraparesis. This group also includes HTLV-II, which is associated with a T-cell malignancy different from ATL. A newly isolated human retrovirus, termed HTLV-V, may be the etiologic agent of cutaneous T-cell lymphoma/leukemia, and may also be added to this group. HIV, previously known as HTLV-III or lymphadenopathy virus (LAV), a nontransforming virus, causes acquired immunodeficiency syndrome (AIDS) and is the prototype of the second group (HIVs). New members of this group of nontransforming human retroviruses were isolated from individuals in different countries of Africa. LAV-2, also referred to as HIV-2, was isolated from two AIDS patients in Africa, and the first case of AIDS in the United States caused by HIV-2 was reported in January, 1988. A third member of this group, HIV-3, was de
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Heart, Lung, and Blood Institute (NHLBI)

Dates:
Date Received: May 25, 2000
Date Started: July 1989
Date Completion:
Last Updated: April 14, 2016
Last Verified: January 2008