HIVNCT01084954
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
An observational study of HIV and HIV Infections, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infections
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Infectious Disease Clinic, HIV Positive patients
Who may be able to join
- 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
Who cannot join
- Patient unable to provide informed consent.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
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.
- Conditions
- HIV, HIV Infections
- Keywords
- HIV validation helicase-dependent amplification
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
A false negative or false positive rate of > 1.0% would make this test unacceptable as a screening test for HIV viremia.
Measured: Participation will last 1 hour for subjects to consent and provide a single blood sample.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Simon, M.D., Ph.D., Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084954
- Sponsor's protocol ID
- 040907
- Status last verified
- Aug 2015
- First submitted
- 9 Mar 2010
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
- ClinicalTrials.gov ID
- NCT01084954
- Acronym / sponsor ID
- 040907
- Conditions
- HIV, HIV Infections
- Keywords
- HIV validation helicase-dependent amplification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Infectious Disease Clinic, HIV Positive patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient unable to provide informed consent.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Simon, M.D., Ph.D. principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and HIV Infections, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.