Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by George Washington University
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01084954
First received: March 9, 2010
Last updated: August 20, 2013
Last verified: August 2013

March 9, 2010
August 20, 2013
March 2009
April 2014   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01084954 on ClinicalTrials.gov Archive Site
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Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Infectious Disease clinic

  • HIV
  • HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current patient in the Medical Faculty Associates ID clinic with known HIV infection
  • Suspected to be viremic at the time of their clinic visit based on history and/or current symptoms
  • Able to provide informed consent
  • 18 Years or older

Exclusion Criteria:

  • Patient unable to provide informed consent.
  • Pregnancy
Both
18 Years and older
No
United States
 
NCT01084954
040907
No
George Washington University
George Washington University
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Principal Investigator: Gary Simon, M.D., Ph.D. George Washington University
George Washington University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP