HIV-1Phase 4NCT00840762
A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
A Phase 4 study testing VircoType HIV-1 genotypic interpretation and Local Expert Review of HIV Genotypic resistance testing in people with HIV-1 and HIV Infections, run by Ruth M. Rothstein CORE Center at 1 site in United States.
Trial summary
The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV-1, HIV Infections
- What is being tested?
- VircoType HIV-1 genotypic interpretation and Local Expert Review of HIV Genotypic resistance testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2012
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV resistance testing that demonstrates resistance to at least one drug
- Patients of the CORE Center, Chicago Illinois
Who cannot join
- Wild type HIV on resistance testing or less than or equal to one active antiretroviral medication
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
David E Barker, MD
Harold A Kessler, MD
About this study
Official title: A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time point equal to or greater than 2 months and 6 months following the change in antiretroviral medications following the testing
Read the detailed description
Patients having some documented genotypic HIV resistance but having more than one fully active medication will be randomized to either local review or algorithmic review by VircoType HIV-1.
- Conditions
- HIV-1, HIV Infections
- Being tested
- VircoType HIV-1 genotypic interpretation, Local Expert Review of HIV Genotypic resistance testing
- Keywords
- HIV-1, HIV, HIV Genotypic testing, resistance
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VircoType HIV-1 genotypic interpretationOther
VircoType HIV-1 genotypic interpretation
Local Expert Review of HIV Genotypic resistance testingOther
Local Expert Review of HIV Genotypic resistance testing
| Study group | Role | What they receive |
|---|---|---|
| VircoType HIV-1 | Experimental | Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm Receives: Other: VircoType HIV-1 genotypic interpretation |
| Local Expert review | Active comparator | Local Expert HIV genotypic review, as per Badri, S. et al CID 2003 Receives: Other: Local Expert Review of HIV Genotypic resistance testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with viral load <1000 60days after HIV regimen change
Measured: 60 days
Proportion of patients with viral load <1000 180 days after HIV regimen change
Measured: 180 days
Secondary outcomes (5)
Proportion of patients with undetectable viral load 60days after HIV regimen change
Measured: 60 days
Proportion of patients with undetectable viral load 180days after HIV regimen change
Measured: 180 days
CD4 Cell count change in each arm at 60 and 180 days
Measured: 60 and 180 days
Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days
Measured: 180 and 360 days
Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruth M. Rothstein CORE Center
- Sponsor type
- University, hospital or other
- Collaborators
- Virco
- Investigators
- David E Barker, MD, Principal investigator, Ruth M. Rothstein CORE Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840762
- Sponsor's protocol ID
- 07-118
- Status last verified
- Jan 2010
- First submitted
- 9 Feb 2009
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Badri SM, Adeyemi OM, Max BE, Zagorski BM, Barker DE. How does expert advice impact genotypic resistance testing in clinical practice? Clin Infect Dis. 2003 Sep 1;37(5):708-13. doi: 10.1086/377266. Epub 2003 Aug 15.
PubMed 12942405
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
- ClinicalTrials.gov ID
- NCT00840762
- Acronym / sponsor ID
- 07-118
- Conditions
- HIV-1, HIV Infections
- Keywords
- HIV-1, HIV, HIV Genotypic testing, resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- Ruth M. Rothstein CORE CenterUniversity, hospital or other
- Collaborators
- Virco
- Study start
- Mar 2009
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 10 Feb 2009 (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.
The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time point equal to or greater than 2 months and 6 months following the change in antiretroviral medications following the testing
Detailed description
Patients having some documented genotypic HIV resistance but having more than one fully active medication will be randomized to either local review or algorithmic review by VircoType HIV-1.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VircoType HIV-1 | Experimental | Other: VircoType HIV-1 genotypic interpretationGenotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm |
| Local Expert review | Active comparator | Other: Local Expert Review of HIV Genotypic resistance testingLocal Expert HIV genotypic review, as per Badri, S. et al CID 2003 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HIV resistance testing that demonstrates resistance to at least one drug
- Patients of the CORE Center, Chicago Illinois
Key exclusion criteria (1 listed)
- Wild type HIV on resistance testing or less than or equal to one active antiretroviral medication
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 |
|---|---|---|
| VircoType HIV-1 genotypic interpretationVircoType HIV-1 genotypic interpretation | Other | VircoType HIV-1 |
| Local Expert Review of HIV Genotypic resistance testingLocal Expert Review of HIV Genotypic resistance testing | Other | Local Expert review |
Primary outcome
Proportion of patients with viral load <1000 60days after HIV regimen change
Time frame: 60 days
Proportion of patients with viral load <1000 180 days after HIV regimen change
Time frame: 180 days
5 secondary outcomes
Proportion of patients with undetectable viral load 60days after HIV regimen change
Time frame: 60 days
Proportion of patients with undetectable viral load 180days after HIV regimen change
Time frame: 180 days
CD4 Cell count change in each arm at 60 and 180 days
Time frame: 60 and 180 days
Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days
Time frame: 180 and 360 days
Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
- Background: PubMed 12942405Badri SM, Adeyemi OM, Max BE, Zagorski BM, Barker DE. How does expert advice impact genotypic resistance testing in clinical practice? Clin Infect Dis. 2003 Sep 1;37(5):708-13. doi: 10.1086/377266. Epub 2003 Aug 15.
- The CORE CenterLink provided by the sponsor.
- Cook County Hospital Department of MedicineLink provided by the sponsor.
- UIC College of PharmacyLink provided by the sponsor.
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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.
David E Barker, MD principal investigator
Ruth M. Rothstein CORE Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VircoType HIV-1 genotypic interpretation and Local Expert Review of HIV Genotypic resistance testing in people with HIV-1 and HIV Infections, run by Ruth M. Rothstein CORE Center 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David E Barker, MD (312-572-4503, dbarker@corecenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with viral load <1000 60days after HIV regimen change (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00840762, which also lists 1 linked publication.
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 26 Jan 2010.