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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01084954
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):

March 9, 2010
March 11, 2010
June 16, 2016
March 2009
April 2016   (Final data collection date for primary outcome measure)
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection [ Time Frame: Participation will last 1 hour for subjects to consent and provide a single blood sample. ]
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 or the Cepheid Xpert HIV-1 Quant Assay. 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 Positive patients
  • 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.
 
Completed
153
April 2016
April 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current patient in the Medical Faculty Associates Infectious Diseases (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01084954
040907
No
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Plan to Share IPD: 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 2015