Cardiovascular DiseasesNCT01776151
Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
An observational study of Cardiovascular Diseases and HIV, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, HIV
- How many people
- 337 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2009to Sep 2015
- 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: Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.
Who may be able to join
- Simultaneous co-enrollment in the START study
- Signed informed consent
Who cannot join
- Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.
- Conditions
- Cardiovascular Diseases, HIV
- Keywords
- HIV, cardiovascular diseases, vascular stiffness
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in large artery elasticity (LAE
Large artery elasticity is measured using a tonometer placed on the forearm.
Measured: baseline, Months 1, 4, 8, 12, annually thereafter
Change from baseline in small artery elasticity (SAE)
Small artery elasticity is measured using a tonometer placed on the forearm.
Measured: baseline, Months 1, 4, 8, 12, annually thereafter
Secondary outcomes (1)
Changes in plasma markers of thrombosis and fibrinolysis
Citrated plasma will be collected and stored for central measurement of plasma markers of thrombosis and fibrinolysis in the future.
Measured: baseline, months 4, 8, 12, annually thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study start15 Apr 2009
- Primary completionSep 2015
- Study completionSep 2015
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason V Baker, MD, Study chair, University of MinnesotaDaniel Duprez, MD, PhD, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776151
- Sponsor's protocol ID
- 0603M83587-3
- Status last verified
- Mar 2023
- First submitted
- 18 Sep 2012
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):109-18. doi: 10.1111/hiv.12239.
PubMed 25711329
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
- ClinicalTrials.gov ID
- NCT01776151
- Acronym / sponsor ID
- 0603M83587-3
- Conditions
- Cardiovascular Diseases, HIV
- Keywords
- HIV, cardiovascular diseases, vascular stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Apr 2009 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Jan 2013 (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 purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.
Key inclusion criteria (2 listed)
- Simultaneous co-enrollment in the START study
- Signed informed consent
Key exclusion criteria (1 listed)
- Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation
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
Change from baseline in large artery elasticity (LAE
Time frame: baseline, Months 1, 4, 8, 12, annually thereafter
Large artery elasticity is measured using a tonometer placed on the forearm.
Change from baseline in small artery elasticity (SAE)
Time frame: baseline, Months 1, 4, 8, 12, annually thereafter
Small artery elasticity is measured using a tonometer placed on the forearm.
1 secondary outcome
Changes in plasma markers of thrombosis and fibrinolysis
Time frame: baseline, months 4, 8, 12, annually thereafter
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 21 Mar 2023.
- Derived from this study: PubMed 25711329Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):109-18. doi: 10.1111/hiv.12239.
- INSIGHT network website, including information on the START Arterial Elasticity SubstudyLink 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.
Jason V Baker, MD study chair
University of Minnesota
Daniel Duprez, MD, PhD study chair
University of Minnesota
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 Cardiovascular Diseases and HIV, run by University of Minnesota 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: finished, as of the sponsor's last update on 21 Mar 2023. 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?
Change from baseline in large artery elasticity (LAE (time frame: baseline, Months 1, 4, 8, 12, annually thereafter). 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 NCT01776151, 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 21 Mar 2023.