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

NCT01084954 | Completed

• 1 other identifier: 040907
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; HIV Infections

Keywords

HIV validation helicase-dependent amplification

Outcome Measures

Primary Outcomes (1)

• 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infectious Disease Clinic, HIV Positive patients

You may qualify if:

• 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
• Years or older

You may not qualify if:

• Patient unable to provide informed consent.
• Pregnancy

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The George Washington University Medical Faculty Associates

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

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Gary Simon, M.D., Ph.D.

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 11, 2010
• Study Start: March 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)