Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
|ClinicalTrials.gov Identifier: NCT00004846|
Recruitment Status : Completed
First Posted : March 3, 2000
Last Update Posted : March 4, 2008
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|
|Study Type :||Observational|
|Estimated Enrollment :||30000 participants|
|Official Title:||Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||October 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004846
|United States, Maryland|
|Warren G. Magnuson Clinical Center (CC)|
|Bethesda, Maryland, United States, 20892|