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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

George Washington University

ClinicalTrials.gov Identifier:

NCT01084954

First received: March 9, 2010

Last updated: June 15, 2016

Last verified: August 2015

History of Changes

Purpose

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.

Condition
HIV HIV Infections


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]
A false negative or false positive rate of > 1.0% would make this test unacceptable as a screening test for HIV viremia.


Enrollment:	153
Study Start Date:	March 2009
Study Completion Date:	April 2016
Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Infectious Disease Clinic, HIV Positive patients

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084954

Locations


United States, District of Columbia
The George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037

Sponsors and Collaborators

George Washington University

Investigators


Principal Investigator:	Gary Simon, M.D., Ph.D.	George Washington University

More Information


Responsible Party:	George Washington University
ClinicalTrials.gov Identifier:	NCT01084954 History of Changes
Other Study ID Numbers:	040907
Study First Received:	March 9, 2010
Last Updated:	June 15, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by George Washington University:


HIV validation helicase-dependent amplification

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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