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

This study is currently recruiting participants.

Verified September 2010 by George Washington University

Sponsor:

Information provided by (Responsible Party):

George Washington University

ClinicalTrials.gov Identifier:

NCT01084954

First received: March 9, 2010

Last updated: February 8, 2013

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2010

Last Updated Date

February 8, 2013

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The issue of concern in this study is the reliability of this test. [ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01084954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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. A false negative or false positive rate of >1.0% would make this test unacceptable as a screening test for HIV viremia.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Infectious Disease clinic

Condition ^ICMJE

HIV
HIV Infections

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

April 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Current patient in the Medical Faculty Associates 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01084954

Other Study ID Numbers ^ICMJE

040907

Has Data Monitoring Committee

Responsible Party

George Washington University

Study Sponsor ^ICMJE

George Washington University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gary Simon, M.D., Ph.D.

George Washington University

Information Provided By

George Washington University

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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