Human Immunodeficiency VirusNCT02461576
Clinical Evaluation of the Xpert® HIV-1 VL
An observational study of Human Immunodeficiency Virus, run by Cepheid.
Trial summary
Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Xpert HIV-1 VL Assay
- Type of treatment
- Medical device
- How many people
- 966 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 24 Feb 2017
- 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: Males and females >18 yours who are known HIV-1 infected and may be on treatment or untreated with ARV therapy
Who may be able to join
- HIV-1 seropositive adults using an FDA approved method
- At least 18 years of age or older
- Informed consent, if applicable
Who cannot join
- Subject is less than 18 years of age
- Previously enrolled in this study
- Samples not collected according to the procedure
About this study
Official title: Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study
Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Xpert HIV-1 VL Assay
- Keywords
- HIV-1
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert HIV-1 VL AssayDevice
in vitro diagnostic test to quantify HIV-1 RNA
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 infected | this is a study comparing Xpert HIV-1 VL assay quantitation to an already FDA approved HIV-1 quantitative HIV-1 RNA assay in known HIV-1 infected individuals Receives: Device: Xpert HIV-1 VL Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects
This study is a comparative analysis of HIV-1 RNA quantitation between Xpert HIV-1 VL to another FDA approved test. A single time point (cross-sectional) from each of at least 300 subjects with HIV-1 RNA quantitation within the dynamic range of both assays will be used in regression models to assess performance of the Xpert HIV-1 VL in comparison to the other FDA approved test.
Measured: 1 day (A single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion24 Feb 2017
- Study completion24 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 966 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461576
- Sponsor's protocol ID
- 177B
- Status last verified
- Feb 2018
- First submitted
- 26 May 2015
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study
- ClinicalTrials.gov ID
- NCT02461576
- Acronym / sponsor ID
- 177B
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 966 participants (actual)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 3 Jun 2015 (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.
Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 infected | – | Device: Xpert HIV-1 VL Assaythis is a study comparing Xpert HIV-1 VL assay quantitation to an already FDA approved HIV-1 quantitative HIV-1 RNA assay in known HIV-1 infected individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females >18 yours who are known HIV-1 infected and may be on treatment or untreated with ARV therapy
Key inclusion criteria (3 listed)
- HIV-1 seropositive adults using an FDA approved method
- At least 18 years of age or older
- Informed consent, if applicable
Key exclusion criteria (3 listed)
- Subject is less than 18 years of age
- Previously enrolled in this study
- Samples not collected according to the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert HIV-1 VL Assayin vitro diagnostic test to quantify HIV-1 RNA | Device | HIV-1 infected |
Primary outcome
Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects
Time frame: 1 day (A single time point)
This study is a comparative analysis of HIV-1 RNA quantitation between Xpert HIV-1 VL to another FDA approved test. A single time point (cross-sectional) from each of at least 300 subjects with HIV-1 RNA quantitation within the dynamic range of both assays will be used in regression models to assess performance of the Xpert HIV-1 VL in comparison to the other FDA approved test.
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 6 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Cepheid.
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 3 inclusion and 3 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 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects (time frame: 1 day (A single time point)). 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 6 Feb 2018.