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

NCT ID: NCT01084954

Last Updated: 2016-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV HIV Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

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The George Washington University Medical Faculty Associates

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

Site Status

Countries

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United States

Other Identifiers

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040907

Identifier Type: -

Identifier Source: org_study_id

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