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Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV

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. Identifier: NCT00004846
Recruitment Status : Completed
First Posted : March 3, 2000
Last Update Posted : March 4, 2008
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

This study will evaluate the accuracy of an experimental test method called nucleic acid amplification technology (NAT) in detecting human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This test amplifies the nucleic acid in a virus more than a million-fold, allowing early detection of minute quantities of virus in the blood.

Blood donors to the National Institutes of Health's Department of Transfusion Medicine (blood bank) will have their blood screened with transcription mediated amplification, a type of NAT test. Donors whose blood is found positive for HIV or HCV by NAT testing will be notified and asked to participate in this study. Those who agree will provide a blood sample about once a week for 3 months. The samples will be tested with additional assays to detect evidence of HIV or HCV infection. If the test results are confirmed positive, no more blood samples will be collected. The results of the tests and their significance will be explained to participants.

It is anticipated that NAT screening will reduce the risk of transfusion-related HIV transmission from the current 1 in 650,000 to 1 in a million and the risk of HCV transmission from the current 1 in 100,000 to 1 in 350,000. It is possible that these tests will completely eliminate the risk of transmitting these diseases through blood transfusion.

Condition or disease Intervention/treatment
Hepatitis C HIV Infection Drug: ABC/Gen-Probe/Chiron HIV-1/HCV 001

Detailed Description:
In order to narrow the infectious period (window) between the time of viral exposure and the time a virus can be serologically detected, blood centers throughout the United States are implementing nucleic acid testing (NAT) for HIV and HCV. Early studies have shown that NAT testing can significantly narrow the infectious window, particularly for HCV. There is the potential that NAT testing could completely eradicate the transfusion risk of HIV and HCV. The test is thus likely to add substantially to the safety of blood transfusions and, although not licensed, has been implemented by all blood suppliers and transfusion services in the United States. NAT testing is currently being used under an IND mechanism. The IND stipulates that blood donors need to be informed through a supplemental information packet that such testing is being performed and that if found positive they may be recalled for additional testing. At the time of recall, an IRB approved study-specific informed consent is administered and additional tests are performed to verify the initial NAT result. The Department of Transfusion medicine is participating in this national validation of NAT testing and will provide donor samples for centralized testing and statistical reporting to FDA. The potential benefits of this testing for blood safety are great and the risk to donors is considered minimal. Not seeking subjects for enrollment.

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Study Type : Observational
Enrollment : 30000 participants
Official Title: Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
Study Start Date : December 1999
Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

All eligible, volunteer NIH blood donors will be tested by NAT. Thus, any donor who enters the system and has blood drawn for viral testing will be a potential candidate for the follow-up study if he/she tests NAT positive for HCV or HIV.

Only potential donors who exclude themselves from the donation process will be excluded from the study.

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 identifier (NCT number): NCT00004846

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United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Layout table for additonal information Identifier: NCT00004846    
Other Study ID Numbers: 000048
First Posted: March 3, 2000    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: October 2002
Keywords provided by National Institutes of Health Clinical Center (CC):
Viral Gene Amplification
Blood Transmitted Infections
Transfusion Risks
Transcription Mediated Analysis
Viral Detection Assays
HIV Seronegativity
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections