Retrovirus Epidemiology Donor Study I (REDS I)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005278
First received: May 25, 2000
Last updated: April 14, 2016
Last verified: January 2008
  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

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  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: 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 
Study First Received: May 25, 2000
Last Updated: April 14, 2016
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 24, 2016