|
Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV Clinical research trials and Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV. Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV clinical trial. Subjects often receive the most expert healthcare possible for their Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "N" Clinical Trials Conditions > Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV  Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
For Condition: Hepatitis C,HIV Infection
Status: Completed
Sponsor(s): Warren G Magnuson Clinical Center (CC) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 30000
Location and Contact Information:
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000048; 00-CC-0048
Study Start Date: December 22, 1999
Record last reviewed: October 17, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004846
Other Hiv Infection Studies:
1. Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected with HCV Genotype 2 or 3
2. Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients with HIV and Hepatitis C Virus
3. Hepatitis C Antiviral Resistance in African-Americans
4. The Impact of HAART on Response to Hepatitis C Treatment in Patients Taking Peginterferon alpha-2b and Ribavirin
5. History of Hepatitis C in Volunteer Blood Donors
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
|
|
|
|
|
|
|
|
