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Retrovirus Epidemiology Donor Study I (REDS I)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005278
First Posted: May 26, 2000
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition
Acquired Immunodeficiency Syndrome Blood Donors Blood Transfusion HIV Infections HIV-1 HIV-2 HTLV-I HTLV-II Retroviridae Infections

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1989
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005278


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: George Garratty American Red Cross Blood Services
OverallOfficial: Martha Higgens American Red Cross Blood Services
OverallOfficial: Edward Murphy University of California at San Francisco
OverallOfficial: Catharie Nass American Red Cross Blood Services
OverallOfficial: George Schreiber Westat, Inc.
OverallOfficial: James Smith Oklahoma Blood Institute
  More Information

Publications:

Study Data/Documents: Operations Manual  This link exits the ClinicalTrials.gov site
Identifier: REDS-GSR/GLPR
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.
Data Dictionary  This link exits the ClinicalTrials.gov site
Identifier: REDS-HHV8
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.
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: REDS-HTLV
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.
Study Forms  This link exits the ClinicalTrials.gov site
Identifier: REDS-HTLV
Operations Manual  This link exits the ClinicalTrials.gov site
Identifier: REDS-RADAR
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.
Operations Manual  This link exits the ClinicalTrials.gov site
Identifier: REDS-SR
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.

ClinicalTrials.gov Identifier: NCT00005278     History of Changes
Other Study ID Numbers: 1501
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: April 15, 2016
Last Verified: January 2008

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Lentivirus Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases