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

George Washington University153 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

153

Conditions

HIV HIV Infections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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

A false negative or false positive rate of \> 1.0% would make this test unacceptable as a screening test for HIV viremia.

Time frame: Participation will last 1 hour for subjects to consent and provide a single blood sample.

Data from ClinicalTrials.gov

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