HIV InfectionsPhase 2/3NCT00986999
Effect of Rosuvastatin on Endothelial Function
A Phase 2/3 study testing rosuvastatin in people with HIV Infections and Cardiovascular Disease, run by University of Hawaii at 1 site in United States.
Trial summary
Rosuvastatin belongs to a class of medications commonly called "statins" which are medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other circulation problems. 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, Cardiovascular Disease
- What is being tested?
- rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- HIV infection
- Age > 18 years old
- On stable antiretroviral therapy for > 6 months with no plans to change therapy during the treatment phase of the study
- Plasma HIV RNA < 50 copies/mL
- Karnofsky performance score > 70 within 30 days prior to study entry
- Ability to understand and sign informed consent
Show all 18Show fewer
- Following laboratory values obtained within 30 days prior to randomization:
- Absolute neutrophil count (ANC) > 750/mm3
- Hemoglobin >/= 8.0 g/dL
- Platelets >/= 50,000/mm3
- ALT (SGPT) and AST (SGOT) < 2.5 x ULN
- Fasting glucose < 126 mg/dL
- TSH < 3.0 mIU/L
- HDL-C < 50 mg/dL in men, < 55 mg/dL in women
- Direct LDL-C </= 130 mg/dL
- Calculated creatinine clearance > 50 mL/min
- Willing to be treated with rosuvastatin or be on an observational arm for a minimum of 3 months
- Female subject must not participate in a conception process (active attempt to become pregnant) or be post-menopausal. If participating in sexual activity that could lead to pregnancy, the subject must use contraception while receiving study medication and 30 days after stopping the medication
Who cannot join
- History of past cardiovascular event
- Acute illnesses or active AIDS-defining opportunistic infection (OI) within 30 days prior to entry
- Other chronic illness including diabetes, autoimmune diseases, and endocrinopathies
- Serology positive for hepatitis B surface antigen or hepatitis C antibody
- Signs and symptoms of liver failure
- Receipt of supraphysiologic glucocorticoid therapy within 3 months prior to study entry
Show all 16Show fewer
- Use of lipid lowering agents within 30 days prior to study entry
- Receipt of an HIV vaccine or investigational agents
- Pregnancy or breast-feeding
- Presence of any active malignancy within the last 5 years
- Severe Hypertension (Systolic >/= 180 or Diastolic >/= 110 mm Hg)
- Use of oral postmenopausal hormone replacement therapy
- Known hypersensitivity to rosuvastatin
- Active drug or alcohol dependence
- Any acute illness within 30 days prior to study entry that, in the opinion of the site investigator, would interfere with participation in the study.
- Use of lopinavir/ritonavir (Kaletra) as part of current HIV antiretroviral regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Effect of Low-Dose Rosuvastatin on Endothelial Function, Oxidative Stress and Inflammatory Parameters in HIV-Infected Individuals With Low HDL Cholesterol Levels and Low to Normal LDL Cholesterol Levels
Rosuvastatin belongs to a class of medications commonly called "statins" which are medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other circulation problems. Recent studies in the general non-HIV infected population have shown that the beneficial effect of statins in preventing circulation problems is larger than would be expected from lowering of LDL-cholesterol alone. It has been suggested that the additional beneficial effect of statins may be due to the anti-inflammatory effect of statins.
The risk of heart attacks and other circulation problems may be high in HIV infected individuals. This may be due to the inflammatory stress effects of HIV. The main purpose of the study is to see if rosuvastatin will have a beneficial effect on the circulatory system in HIV infected individuals even in those who do not have high LDL cholesterol levels. Therefore, in HIV-infected individuals with normal or low LDL cholesterol levels but with evidence of low HDL cholesterol levels which may be a sign of low grade inflammation, the study will look at whether 3 months of rosuvastatin will lead to improvement in brachial artery flow-mediated dilatation (FMD), a marker of early atherosclerosis (hardening of the blood vessels).
- Conditions
- HIV Infections, Cardiovascular Disease
- Being tested
- rosuvastatin
- Keywords
- HIV infected, treatment experienced
- Medical subject headings
- HIV Infections, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
Also called Crestor
rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years
| Study group | Role | What they receive |
|---|---|---|
| rosuvastatin | Experimental | rosuvastatin 10 mg qd increased to 20 mg qd as tolerated Receives: Drug: rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow Mediated Dilatation (FMD) of the Brachial Artery
Measured: 3 months
Secondary outcomes (5)
Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes
Measured: 3 months
Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels
Measured: 3 months
Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing
Measured: 3 months
Change in Total, HDL and LDL Cholesterol and Triglyceride Levels
Measured: 3 months
Change in hsCRP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2015
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Shikuma, MD, Principal investigator, Hawaii Center for AIDS, John A. Burns School of Medicine, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986999
- Sponsor's protocol ID
- H002
- Other IDs
- R01HL095135
- Status last verified
- Jan 2015
- First submitted
- 29 Sep 2009
- Last updated
- 29 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Low-Dose Rosuvastatin on Endothelial Function, Oxidative Stress and Inflammatory Parameters in HIV-Infected Individuals With Low HDL Cholesterol Levels and Low to Normal LDL Cholesterol Levels
- ClinicalTrials.gov ID
- NCT00986999
- Acronym / sponsor ID
- H002
- Conditions
- HIV Infections, Cardiovascular Disease
- Keywords
- HIV infected, treatment experienced
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2015 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Posted 29 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rosuvastatin belongs to a class of medications commonly called "statins" which are medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other circulation problems. Recent studies in the general non-HIV infected population have shown that the beneficial effect of statins in preventing circulation problems is larger than would be expected from lowering of LDL-cholesterol alone. It has been suggested that the additional beneficial effect of statins may be due to the anti-inflammatory effect of statins.
The risk of heart attacks and other circulation problems may be high in HIV infected individuals. This may be due to the inflammatory stress effects of HIV. The main purpose of the study is to see if rosuvastatin will have a beneficial effect on the circulatory system in HIV infected individuals even in those who do not have high LDL cholesterol levels. Therefore, in HIV-infected individuals with normal or low LDL cholesterol levels but with evidence of low HDL cholesterol levels which may be a sign of low grade inflammation, the study will look at whether 3 months of rosuvastatin will lead to improvement in brachial artery flow-mediated dilatation (FMD), a marker of early atherosclerosis (hardening of the blood vessels).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rosuvastatin | Experimental | Drug: rosuvastatinrosuvastatin 10 mg qd increased to 20 mg qd as tolerated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- HIV infection
- Age > 18 years old
- On stable antiretroviral therapy for > 6 months with no plans to change therapy during the treatment phase of the study
- Plasma HIV RNA < 50 copies/mL
- Karnofsky performance score > 70 within 30 days prior to study entry
Key exclusion criteria (16 listed)
- History of past cardiovascular event
- Acute illnesses or active AIDS-defining opportunistic infection (OI) within 30 days prior to entry
- Other chronic illness including diabetes, autoimmune diseases, and endocrinopathies
- Serology positive for hepatitis B surface antigen or hepatitis C antibody
- Signs and symptoms of liver failure
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 |
|---|---|---|
| rosuvastatinAlso: Crestorrosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years | Drug | rosuvastatin |
Primary outcome
Change in Flow Mediated Dilatation (FMD) of the Brachial Artery
Time frame: 3 months
5 secondary outcomes
Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes
Time frame: 3 months
Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels
Time frame: 3 months
Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing
Time frame: 3 months
Change in Total, HDL and LDL Cholesterol and Triglyceride Levels
Time frame: 3 months
Change in hsCRP
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
Cecilia Shikuma, MD principal investigator
Hawaii Center for AIDS, John A. Burns School of Medicine, University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rosuvastatin in people with HIV Infections and Cardiovascular Disease, run by University of Hawaii 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 18 inclusion and 16 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: stopped early, as of the sponsor's last update on 29 Jan 2015. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Flow Mediated Dilatation (FMD) of the Brachial Artery (time frame: 3 months). 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 29 Jan 2015.