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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by George Washington University
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01084954
First received: March 9, 2010
Last updated: August 13, 2014
Last verified: August 2014
  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:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infectious Disease clinic

Criteria

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
  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

Contacts
Contact: Nicole Swanson 202-741-2230

Locations
United States, District of Columbia
The George Washington University Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Principal Investigator: Gary L Simon, M.D., Ph.D.         
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Gary Simon, M.D., Ph.D. George Washington University
  More Information

No publications provided

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: August 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
HIV validation helicase-dependent amplification

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014