Retrovirus Epidemiology Donor Study I (REDS I)
Primary Purpose
Acquired Immunodeficiency Syndrome, Blood Donors, Blood Transfusion
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Acquired Immunodeficiency Syndrome
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005278
First Posted
May 25, 2000
Last Updated
April 14, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005278
Brief Title
Retrovirus Epidemiology Donor Study I (REDS I)
Study Type
Observational
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 1989 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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 Description
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 detected in Africa.
Although the HTLV family of retroviruses is distinct from the HIV family, both groups of viruses infect human T4 (CD4) lymphocytes preferentially and alter the host's T-cell functions. Whereas HTLV-I or HTLV-II primarily induce transformation and proliferation of T Lymphocytes and cause T-cell lymphoma/leukemia in humans, HIV and HIV-2 induce T-cell cytopathology that leads to depletion of CD4 cells.
The spread of HIV by blood transfusion represents a highly efficient mode of transmission. Blood components from donors with antibody to HIV have been shown to transmit the virus with frequencies of greater than 90 percent. Packed red blood cells, platelets, or fresh frozen plasma are all equally effective in transmitting the virus to recipients. It is highly likely, therefore, that recipients who receive blood from donors with antibody to HIV will themselves become infected with the virus. Fortunately, the likelihood of such an occurrence in the United States is now rare due to the implementation of screening procedures and other safeguards. When the study was initiated in 1989, there was a growing concern, however, that human retroviruses other than HIV might threaten the safety of the United States blood supply.
DESIGN NARRATIVE:
Blood donors were asked to participate in this multicenter study. Seropositive donors were notified of test results, counseled, and invited to join the follow-up study. Data collected during the first interview included such items as possible exposures to persons with retroviral infection, sexual preferences and contacts, marital history, intravenous drug use, occupation, travel, knowledge of AIDS and routes of HIV transmission. At subsequent visits a blood specimen was collected for laboratory testing and an assessment made of changes in behavior to reduce the risk of virus transmission.
To calculate incidence and prevalence rates, each center identified the appropriate study population for analysis purposes in collaboration with the coordinating center. For prevalence calculations, the study population consisted of donors at all centers who indicated that they had never donated blood previously. To calculate incidence, the study population consisted of donors who had donated previously in the same center. The incidence of retroviral infections was assessed annually in years three through five. Clinical follow-up of all subjects concluded 48 months after the beginning of enrollment. A blood profile for each center was required to calculate denominator values for incidence and prevalence determinations. The blood profile, or donor demographic characterization consisted of information regarding total donor volume with respect to donation status; new or repeat donor, and if repeat, the time of last donation; age; sex; and race.
An adjunct to the study was the development of repositories of plasma and cell samples from infected donors and negative controls collected at the same time. A potential byproduct of these repositories will be the ability in future years to retrospectively search the REDS frozen repository file for new retroviruses which may appear in the United States population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, Blood Donors, Blood Transfusion, HIV Infections, HIV-1, HIV-2, HTLV-I, HTLV-II, Retroviridae Infections
7. Study Design
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Garratty
Organizational Affiliation
American Red Cross Blood Services
First Name & Middle Initial & Last Name & Degree
Martha Higgens
Organizational Affiliation
American Red Cross Blood Services
First Name & Middle Initial & Last Name & Degree
Edward Murphy
Organizational Affiliation
University of California at San Francisco
First Name & Middle Initial & Last Name & Degree
Catharie Nass
Organizational Affiliation
American Red Cross Blood Services
First Name & Middle Initial & Last Name & Degree
George Schreiber
Organizational Affiliation
Westat, Inc.
First Name & Middle Initial & Last Name & Degree
James Smith
Organizational Affiliation
Oklahoma Blood Institute
12. IPD Sharing Statement
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15819666
Citation
Tobler LH, Bianco C, Glynn SA, Schreiber GB, Dille BJ, Prince HE, Lanciotti RS, Linnen JM, Gallarda J, Shyamala V, Smith D, Kleinman SH, Busch MP; NHLBI Retrovirus Epidemiology Study (REDS). Detection of West Nile virus RNA and antibody in frozen plasma components from a voluntary market withdrawal during the 2002 peak epidemic. Transfusion. 2005 Apr;45(4):480-6. doi: 10.1111/j.0041-1132.2005.04266.x.
Results Reference
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PubMed Identifier
15819665
Citation
Kleinman S, Glynn SA, Busch M, Todd D, Powell L, Pietrelli L, Nemo G, Schreiber G, Bianco C, Katz L; NHLBI Retrovirus Epidemiology Study (REDS). The 2003 West Nile virus United States epidemic: the America's Blood Centers experience. Transfusion. 2005 Apr;45(4):469-79. doi: 10.1111/j.0041-1132.2005.04315.x.
Results Reference
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PubMed Identifier
15987350
Citation
Kleinman SH, Glynn SA, Higgins MJ, Triulzi DJ, Smith JW, Nass CC, Garratty G, Murphy EL, LeParc GF, Schreiber GB, King MR, Chamberland ME, Nemo GJ. The RADAR repository: a resource for studies of infectious agents and their transmissibility by transfusion. Transfusion. 2005 Jul;45(7):1073-83. doi: 10.1111/j.1537-2995.2005.00171.x.
Results Reference
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Available IPD and Supporting Information:
Available IPD/Information Type
Operations Manual
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/gsrglpr/
Available IPD/Information Identifier
REDS-GSR/GLPR
Available IPD/Information Comments
Samples and characterization data. NHLBI provides controlled access to samples through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a materials use agreement.
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/reds/
Available IPD/Information Identifier
REDS-HTLV
Available IPD/Information Comments
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Available IPD/Information Type
Study Forms
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/reds/
Available IPD/Information Identifier
REDS-HTLV
Available IPD/Information Type
Operations Manual
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/radar/
Available IPD/Information Identifier
REDS-RADAR
Available IPD/Information Comments
Samples and characterization data. NHLBI provides controlled access to samples through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a materials use agreement.
Learn more about this trial
Retrovirus Epidemiology Donor Study I (REDS I)
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