High Triglyceride LevelPhase 4HOSTNCT01041521
The Impact of Omega Three Fatty Acids on Vascular Function in HIV
A Phase 4 study testing Lovaza in people with High Triglyceride Level and HIV Infection, run by Tufts University at 1 site in United States.
Trial summary
The study seeks to determine if the use of omega three fatty acids in individuals infected with HIV and with high triglycerides leads to improved triglyceride levels, better blood vessel function and decrease in the amount of obstruction in blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Triglyceride Level, HIV Infection
- What is being tested?
- Lovaza
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected men and women at least 18 years of age,
- On stable HAART for the previous two months and without anticipated changes in their HAART regimen throughout the duration of the study,
- Fasting triglycerides > 150 mg/dl and < 2,500 mg/dl
- Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changed during the course of the study.
- Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), and Estrogens (e.g., Estinyl; Estrace; Estraderm), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke.
- Female participants of reproductive age must not be pregnant (negative test) or lactating at screening and throughout the trial and agree to use contraception for the course of the trial and 2 months after the trial unless they are surgically sterilized (tubal ligation or hysterectomy), or post-menopausal with no menses for > 1 year.
- Ability to provide consent.
Who cannot join
- plasma HIV-1 RNA > 10,000 copies/ml
- change in HAART regimen over two months prior to study entry
- change in lipid lowering therapy within 2 months (8 weeks)
- Pregnancy in female participants
- Evidence of liver or renal disease with values of liver enzymes > 5 X upper limit of normal or creatinine > 1.5 X upper limit of normal
- presence of active opportunistic infection or malignancy
Show all 10Show fewer
- presence of other inflammatory or end organ disease (, rheumatoid arthritis, active treatment for hepatitis c, or other diseases that may alter inflammatory markers)
- routine ingestion of fish oil (individuals who have used fish oil would be reconsidered for study participation if they discontinue use of fish oil for 8 weeks and TG levels remain elevated).
- Allergic to fish or Lovaza
- BMI >35
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Medicine
Boston, Massachusetts, 02111
About this study
The study seeks to determine if the use of omega three fatty acids in individuals infected with HIV and with high triglycerides leads to improved triglyceride levels, better blood vessel function and decrease in the amount of obstruction in blood vessels.
Read the detailed description
While omega-three fatty acids have been shown to be beneficial for triglycerides (TG) and HDL-C levels in HIV uninfected individuals and in some small, short duration studies in HIV-infected individuals, there are no data that extend these observations to determine whether intake of omega-three fats over a more prolonged time period will also have a beneficial impact on functional outcomes such as vascular endothelial function and anatomic surrogate markers of cardiovascular disease (CVD) in HIV-infected patients.
We propose a randomized, double blind trial of purified omega-three fatty acids in HIV-infected individuals with elevated levels of triglycerides. While the impact of omega-three fatty acids on lipid profiles should be evident early (within 12 weeks); we propose to conduct this trial for a full 24 months to test our overall hypothesis that this intervention will not only improve triglyceride and HDL-C levels, improve HDL-subpopulations, plasma and membrane phospholipids and decrease inflammation, but will also improve brachial artery reactivity testing (BART) as a measure of vascular endothelial function at 24 weeks and 24 months and arterial stiffness measured by a pulse wave velocity test as a surrogate marker of CVD risk at 24 months when compared to controls.
The specific aims of this proposal include:
- To conduct a randomized, placebo controlled trial of omega-three fatty acids over 24 months in HIV-infected individuals with elevated levels of triglycerides (> 150 mg/dl).
- To demonstrate the impact of omega-three fatty acid intake on TG levels and on HDL-C levels, HDL subpopulations, composition of plasma and membrane phospholipids, and chronic inflammation as measured by c-reactive protein (CRP), sPLA2 and by levels of arachidonic acid.
- To demonstrate the impact of omega-three fatty acid intake on BART at 24 weeks and 24 months and on arterial stiffness at 24 months.
- Conditions
- High Triglyceride Level, HIV Infection
- Being tested
- Lovaza
- Keywords
- HIV infection, Dyslipidemia, Elevated Triglyceride level, vascular function (BART), arterial stiffness, omega three fatty acids, complementary therapies
- Medical subject headings
- HIV Infections, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovazaDrug
Also called omega three fatty acids, previously known as Omacor
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Lovaza (omega three fatty acid) | Experimental | Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
Other Names:
Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules Receives: Drug: Lovaza |
| sugar pill | No intervention | Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride Level
Measured: 24 months
Secondary outcomes (1)
Vascular Function
Carotid-femoral pulse wave velocity is a measure of arterial stiffness, with lower values indicating less arterial stiffness.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2014
- Study completionAug 2015
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 High Triglyceride LevelStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christine A Wanke, MD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041521
- Sponsor's protocol ID
- LVZ112667
- Other IDs
- 1R01HL096585-01A1
- Acronym
- HOST
- Status last verified
- Feb 2020
- First submitted
- 30 Dec 2009
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Omega Three Fatty Acids on Vascular Function in HIV
- ClinicalTrials.gov ID
- NCT01041521
- Acronym / sponsor ID
- HOST / LVZ112667
- Conditions
- High Triglyceride Level, HIV Infection
- Keywords
- HIV infection, Dyslipidemia, Elevated Triglyceride level, vascular function (BART), arterial stiffness, omega three fatty acids, complementary therapies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Dec 2009 (estimated)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to determine if the use of omega three fatty acids in individuals infected with HIV and with high triglycerides leads to improved triglyceride levels, better blood vessel function and decrease in the amount of obstruction in blood vessels.
Detailed description
While omega-three fatty acids have been shown to be beneficial for triglycerides (TG) and HDL-C levels in HIV uninfected individuals and in some small, short duration studies in HIV-infected individuals, there are no data that extend these observations to determine whether intake of omega-three fats over a more prolonged time period will also have a beneficial impact on functional outcomes such as vascular endothelial function and anatomic surrogate markers of cardiovascular disease (CVD) in HIV-infected patients.
We propose a randomized, double blind trial of purified omega-three fatty acids in HIV-infected individuals with elevated levels of triglycerides. While the impact of omega-three fatty acids on lipid profiles should be evident early (within 12 weeks); we propose to conduct this trial for a full 24 months to test our overall hypothesis that this intervention will not only improve triglyceride and HDL-C levels, improve HDL-subpopulations, plasma and membrane phospholipids and decrease inflammation, but will also improve brachial artery reactivity testing (BART) as a measure of vascular endothelial function at 24 weeks and 24 months and arterial stiffness measured by a pulse wave velocity test as a surrogate marker of CVD risk at 24 months when compared to controls.
The specific aims of this proposal include:
- To conduct a randomized, placebo controlled trial of omega-three fatty acids over 24 months in HIV-infected individuals with elevated levels of triglycerides (> 150 mg/dl).
- To demonstrate the impact of omega-three fatty acid intake on TG levels and on HDL-C levels, HDL subpopulations, composition of plasma and membrane phospholipids, and chronic inflammation as measured by c-reactive protein (CRP), sPLA2 and by levels of arachidonic acid.
- To demonstrate the impact of omega-three fatty acid intake on BART at 24 weeks and 24 months and on arterial stiffness at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovaza (omega three fatty acid) | Experimental | Drug: LovazaLovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks. Other Names: Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules |
| sugar pill | No intervention | –Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-infected men and women at least 18 years of age,
- On stable HAART for the previous two months and without anticipated changes in their HAART regimen throughout the duration of the study,
- Fasting triglycerides > 150 mg/dl and < 2,500 mg/dl
- Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changed during the course of the study.
- Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), and Estrogens (e.g., Estinyl; Estrace; Estraderm), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke.
Key exclusion criteria (10 listed)
- plasma HIV-1 RNA > 10,000 copies/ml
- change in HAART regimen over two months prior to study entry
- change in lipid lowering therapy within 2 months (8 weeks)
- Pregnancy in female participants
- Evidence of liver or renal disease with values of liver enzymes > 5 X upper limit of normal or creatinine > 1.5 X upper limit of normal
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 |
|---|---|---|
| LovazaAlso: omega three fatty acids, previously known as OmacorLovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months | Drug | Lovaza (omega three fatty acid) |
Primary outcome
Triglyceride Level
Time frame: 24 months
1 secondary outcome
Vascular Function
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Christine A Wanke, MD principal investigator
Tufts University
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 Lovaza in people with High Triglyceride Level and HIV Infection, run by Tufts University 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 7 inclusion and 10 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 11 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2020). 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?
Triglyceride Level (time frame: 24 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 11 Feb 2020.