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

NCT00004846 | Completed

• 2 other identifiers: 00004800-CC-0048
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; HIV Infection

Keywords

Viral Gene Amplification; Blood Transmitted Infections; Transfusion Risks; Transcription Mediated Analysis; Viral Detection Assays; HIV Seronegativity

Interventions

ABC/Gen-Probe/Chiron HIV-1/HCV 001 DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Yerly S, Pedrocchi M, Perrin L. The use of polymerase chain reaction in plasma pools for the concomitant detection of hepatitis C virus and HIV type 1 RNA. Transfusion. 1998 Oct;38(10):908-14. doi: 10.1046/j.1537-2995.1998.381098440854.x.

  PMID: 9767740 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 2, 2000
• First Posted: March 3, 2000
• Study Start: December 1, 1999
• Study Completion: October 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-10

Locations

US (1)