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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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: Mar 11, 2010
Registry last updated: Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed