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

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ClinicalTrials.gov Identifier: NCT01084954
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
George Washington University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
HIV HIV Infections

Study Design
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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
Study Start Date : March 2009
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01084954     History of Changes
Other Study ID Numbers: 040907
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: August 2015
Individual Participant Data (IPD) Sharing Statement:
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