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

June 15, 2016 updated by: George Washington University
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infectious Disease Clinic, HIV Positive patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participation will last 1 hour for subjects to consent and provide a single blood sample.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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