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:
George Washington University
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
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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
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 |
ClinicalTrials.gov processed this record on March 01, 2015