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

Completed

• Conditions: HIV; HIV Infections

• Registration Number: NCT01084954
• Lead Sponsor: George Washington University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Status Verified: 2015-08
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection	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.

Trial Locations

Locations (1)

The George Washington University Medical Faculty Associates; 🇺🇸 Washington, District of Columbia, United States