Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01084954 |
Recruitment Status
:
Completed
First Posted
: March 11, 2010
Last Update Posted
: June 16, 2016
|
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Condition or disease |
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HIV HIV Infections |
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 |

- 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.

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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 |
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

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
United States, District of Columbia | |
The George Washington University Medical Faculty Associates | |
Washington, District of Columbia, United States, 20037 |
Principal Investigator: | Gary Simon, M.D., Ph.D. | George Washington University |
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 |