Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent amplification. A false negative or false positive rate of >1.0% would make this test unacceptable as a screening test for HIV viremia.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection|
- The issue of concern in this study is the reliability of this test. [ Time Frame: single blood sample ] [ Designated as safety issue: No ]A false negative or false positive rate of > 1.0% would make this test unacceptable as a screening test for HIV viremia.
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084954
|United States, District of Columbia|
|The George Washington University Medical Faculty Associates||Recruiting|
|Washington, District of Columbia, United States, 20037|
|Contact: Carol Wingfield, R.N. 202-741-2230|
|Principal Investigator: Gary L Simon, M.D., Ph.D.|
|Principal Investigator:||Gary Simon, M.D., Ph.D.||George Washington University|