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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01084954

Enrollment

153

Registered

2010-03-11

Start date

2009-03-31

Completion date

2016-04-30

Last updated

2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, HIV Infections

Keywords

HIV validation helicase-dependent amplification

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results