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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00004846
First received: March 2, 2000
Last updated: March 3, 2008
Last verified: October 2002
  Purpose

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

Study Type: Observational
Official Title: Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 30000
Study Start Date: December 1999
Estimated Study Completion Date: October 2002
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004846

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004846     History of Changes
Other Study ID Numbers: 000048, 00-CC-0048
Study First Received: March 2, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014