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NCT00004846 · ClinicalTrials.gov registry record
Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 30,000
- Enrollment target
NCT00004846 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 30,000 participants.
The verdict
NCT00004846 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 30,000 participants
- Enrollment target
Study 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.
Interventions
- DRUG ABC/Gen-Probe/Chiron HIV-1/HCV 001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30,000 participants |
| Start Date | 1999-12 |
| Est. Completion | 2002-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004846
The ClinicalTrials.gov registry entry for NCT00004846 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ABC/Gen-Probe/Chiron HIV-1/HCV 001 is the first listed.
NCT00004846 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00004846 about?
NCT00004846 is a clinical study titled "Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV". 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 m...
What is the current status of trial NCT00004846?
This trial is currently completed. The enrollment target is 30,000 participants. The study started on 1999-12. Estimated completion is 2002-10.
What interventions are being tested in trial NCT00004846?
The interventions under investigation include: ABC/Gen-Probe/Chiron HIV-1/HCV 001 (DRUG).
Who is sponsoring clinical trial NCT00004846?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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