AtherosclerosisNCT00143624
Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
A study testing Rosiglitazone maleate in people with Atherosclerosis and HIV Infections, run by University of British Columbia at 1 site in Canada.
Trial summary
This trial will study the effect of rosiglitazone on the progression of atherosclerosis (hardening of blood vessels) through improvements of the sugar and fat metabolism (body buildup, breakdown and excretion of sugar and fat). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Atherosclerosis, HIV Infections
- What is being tested?
- Rosiglitazone maleate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2003to Dec 2009
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive
- Between 30 and 70 years of age
- Elevated blood levels of fat
- On two or more anti-HIV drugs for at least12 months in a row and unlikely to change anti-HIV therapy during the study
- On stable regimen for at least 6 months for women taking oral contraceptive agents or hormone replacement
- On a stable regimen for at least 6 months for men on testosterone replacement
- If taking nevirapine, on therapy for at least 3 months with stable liver function tests
Who cannot join
- Pregnancy and breastfeeding
- Poorly controlled diabetes
- Uncontrolled hypertension or clinical evidence of heart failure
- Any serious medical conditions, including an active AIDS-defining condition, pancreatitis, or hepatitis within 6 months prior to the study
- Laboratory abnormalities (see investigator)
- On lipid lowering agents, insulin, anabolic steroids (except for testosterone at replacement doses), oral corticosteroids at greater than replacement doses, or growth hormones
- History of liver reaction or severe edema associated with current thiazolidinedione
- History of hypersensitivity to thiazolidinedione
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rosiglitazone Maleate (Avandia®) on Carotid Intima Media Thickness, Brachial Artery Reactivity, Glucose Metabolism, Blood Lipid Concentrations, Body Fat Distribution, and Biochemical Markers of Cardiovascular Risk in Patients With the HIV Metabolic Syndrome
This trial will study the effect of rosiglitazone on the progression of atherosclerosis (hardening of blood vessels) through improvements of the sugar and fat metabolism (body buildup, breakdown and excretion of sugar and fat).
Participants will be randomly assigned to one of two groups: the first group will receive 8 mg of the study drug and the second group will be given a placebo, though neither group will know which formulation they are receiving. The study will follow both groups for one year, during which it will measure changes in blood vessel composition and activity, sugar metabolism, concentration of blood fat, and body fat distribution. This single-site study aims to enroll 50 participants.
- Conditions
- Atherosclerosis, HIV Infections
- Being tested
- Rosiglitazone maleate, Placebo
- Keywords
- Treatment Experienced, HIV Metabolic Syndrome, Atherosclerosis in HIV
- Medical subject headings
- Atherosclerosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosiglitazone maleateDrug
See Detailed Description.
PlaceboDrug
See detailed description.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The first group will receive 8 mg of the study drug (rosiglitazone). Receives: Drug: Rosiglitazone maleate |
| 2 | Placebo comparator | The second group will be given a placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid intima media thickness (IMT)
Measured: 1 year
Secondary outcomes (4)
Changes in glucose metabolism
Measured: 1 year
Changes in concentrations of blood lipids
Measured: 1 year
Changes in C-reactive protein
Measured: 1 year
Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Greg Bondy, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143624
- Sponsor's protocol ID
- P02-0086
- Other IDs
- CTN 178
- Status last verified
- Dec 2009
- First submitted
- 31 Aug 2005
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rosiglitazone Maleate (Avandia®) on Carotid Intima Media Thickness, Brachial Artery Reactivity, Glucose Metabolism, Blood Lipid Concentrations, Body Fat Distribution, and Biochemical Markers of Cardiovascular Risk in Patients With the HIV Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00143624
- Acronym / sponsor ID
- P02-0086
- Conditions
- Atherosclerosis, HIV Infections
- Keywords
- Treatment Experienced, HIV Metabolic Syndrome, Atherosclerosis in HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Sep 2005 (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.
This trial will study the effect of rosiglitazone on the progression of atherosclerosis (hardening of blood vessels) through improvements of the sugar and fat metabolism (body buildup, breakdown and excretion of sugar and fat).
Participants will be randomly assigned to one of two groups: the first group will receive 8 mg of the study drug and the second group will be given a placebo, though neither group will know which formulation they are receiving. The study will follow both groups for one year, during which it will measure changes in blood vessel composition and activity, sugar metabolism, concentration of blood fat, and body fat distribution. This single-site study aims to enroll 50 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rosiglitazone maleateThe first group will receive 8 mg of the study drug (rosiglitazone). |
| 2 | Placebo comparator | Drug: PlaceboThe second group will be given a placebo. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-positive
- Between 30 and 70 years of age
- Elevated blood levels of fat
- On two or more anti-HIV drugs for at least12 months in a row and unlikely to change anti-HIV therapy during the study
- On stable regimen for at least 6 months for women taking oral contraceptive agents or hormone replacement
Key exclusion criteria (8 listed)
- Pregnancy and breastfeeding
- Poorly controlled diabetes
- Uncontrolled hypertension or clinical evidence of heart failure
- Any serious medical conditions, including an active AIDS-defining condition, pancreatitis, or hepatitis within 6 months prior to the study
- Laboratory abnormalities (see investigator)
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 |
|---|---|---|
| Rosiglitazone maleateSee Detailed Description. | Drug | 1 |
| PlaceboSee detailed description. | Drug | 2 |
Primary outcome
Carotid intima media thickness (IMT)
Time frame: 1 year
4 secondary outcomes
Changes in glucose metabolism
Time frame: 1 year
Changes in concentrations of blood lipids
Time frame: 1 year
Changes in C-reactive protein
Time frame: 1 year
Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)
Time frame: 1 year
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 9 Dec 2009.
- Related InfoLink 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.
Greg Bondy, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosiglitazone maleate in people with Atherosclerosis and HIV Infections, run by University of British Columbia at 1 site in Canada.
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 7 inclusion and 8 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 9 Dec 2009. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Carotid intima media thickness (IMT) (time frame: 1 year). 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 9 Dec 2009.