HIV InfectionsNCT00575939
Antiretrovirals and Rate of Progression in Carotid Artery Intima-medial Thickness in HIV
An observational study of HIV Infections and Atherosclerosis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis. Several cohorts have shown an increased risk of heart disease in people with HIV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Atherosclerosis
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Nov 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 80 HIV-infected adults older than 18 years of age, ART-naïve with CD4 count of at least 400 cells/mm3 The control group will be adults, healthy controls with no active infection or inflammatory condition, who are matched by gender and age to the HIV positive group
Who may be able to join
- HIV-1 infection
- Age at least 18 years
- Naïve to antiretroviral therapy
- CD4 cell count > 400 cells/mm3
- For controls: Age at least 18 years, no known HIV infection, and no known medical condition requiring chronic use of prescription medications.
Who cannot join
- Diabetes
- Pregnant or breastfeeding
- Women of child bearing age who refuse or are unable to use appropriate methods of contraception during the entire study period.
- Active infectious or inflammatory condition
- In jail or involuntarily incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Assessment of the Use of a Metabolically-friendly Antiretroviral Regimen to Slow Down the Rate of Progression in Carotid Artery Intima-medial Thickness in Adults With HIV
It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis. Several cohorts have shown an increased risk of heart disease in people with HIV. The effect of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this study the investigators will assess the effect on carotid IMT of the initiation of antiretroviral combinations that are known to have a minimal effect on lipids and insulin resistance. We will also assess the changes in several inflammation and cardiovascular markers,as well as endothelial activation markers,and how these changes relate to therapy-induced changes in immunologic, virologic and metabolic markers.
- Conditions
- HIV Infections, Atherosclerosis
- Keywords
- HIV, IMT, coronary, Treatment Naive
- Medical subject headings
- HIV Infections, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive | HIV infected treatment naive with CD4 cell count of at least 400 | |
| Healthy controls | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Carotid IMT
Measured: Annualy for 4 years
Secondary outcomes (3)
Increase or decrease in Inflammatory markers
Measured: Annually for 4 years
Changes in Fasting lipids
Measured: Annually for 4 years
Change in Insulin resistance by HOMA score
Measured: Annually for 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Grace McComsey, University Hospitals Cleveland Medical Center
- Investigators
- Grace A McComsey, MD, Principal investigator, Case Western Reserve University and University Hospitals of Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575939
- Sponsor's protocol ID
- AIDS 070711
- Other IDs
- BMS
- Status last verified
- Dec 2014
- First submitted
- 14 Dec 2007
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Use of a Metabolically-friendly Antiretroviral Regimen to Slow Down the Rate of Progression in Carotid Artery Intima-medial Thickness in Adults With HIV
- ClinicalTrials.gov ID
- NCT00575939
- Acronym / sponsor ID
- AIDS 070711
- Conditions
- HIV Infections, Atherosclerosis
- Keywords
- HIV, IMT, coronary, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Dec 2007 (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.
It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis. Several cohorts have shown an increased risk of heart disease in people with HIV. The effect of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this study the investigators will assess the effect on carotid IMT of the initiation of antiretroviral combinations that are known to have a minimal effect on lipids and insulin resistance. We will also assess the changes in several inflammation and cardiovascular markers,as well as endothelial activation markers,and how these changes relate to therapy-induced changes in immunologic, virologic and metabolic markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive | – | –HIV infected treatment naive with CD4 cell count of at least 400 |
| Healthy controls | – | –Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 80 HIV-infected adults older than 18 years of age, ART-naïve with CD4 count of at least 400 cells/mm3 The control group will be adults, healthy controls with no active infection or inflammatory condition, who are matched by gender and age to the HIV positive group
Key inclusion criteria (5 listed)
- HIV-1 infection
- Age at least 18 years
- Naïve to antiretroviral therapy
- CD4 cell count > 400 cells/mm3
- For controls: Age at least 18 years, no known HIV infection, and no known medical condition requiring chronic use of prescription medications.
Key exclusion criteria (5 listed)
- Diabetes
- Pregnant or breastfeeding
- Women of child bearing age who refuse or are unable to use appropriate methods of contraception during the entire study period.
- Active infectious or inflammatory condition
- In jail or involuntarily incarcerated
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
Changes in Carotid IMT
Time frame: Annualy for 4 years
3 secondary outcomes
Increase or decrease in Inflammatory markers
Time frame: Annually for 4 years
Changes in Fasting lipids
Time frame: Annually for 4 years
Change in Insulin resistance by HOMA score
Time frame: Annually for 4 years
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 19 Dec 2014.
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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.
Grace A McComsey, MD principal investigator
Case Western Reserve University and University Hospitals of Cleveland
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 Infections and Atherosclerosis, run by University Hospitals Cleveland Medical 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 5 inclusion and 5 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 19 Dec 2014. 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?
Changes in Carotid IMT (time frame: Annualy for 4 years). 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 19 Dec 2014.