Cardiovascular DiseasePhase 4HALONCT00795717
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
A Phase 4 study testing Lovaza in people with Cardiovascular Disease and HIV Infection, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Disease, HIV Infection
- What is being tested?
- Lovaza
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Oct 2010
- 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 to 65 years
- 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 previous three months and without anticipated changes in their HAART regimen throughout the duration of the study
- Fasting triglycerides > 150 mg/dl and < 1,500 mg/dl
- Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changes during the course of the study
- Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on the 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 2 methods of barrier 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
- Previous history of atherosclerotic disease or diabetes mellitus
- Change in HAART regimen over three months prior to study entry
- Change in lipid lowering therapy within 2 months
- On chronic anticoagulants such as heparin or coumadin
- On fish oil, omega 3 supplements, or Omacor currently or during the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Medicine
Boston, Massachusetts, 02111
About this study
The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.
Read the detailed description
This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, with 12-week treatment periods separated by a 4-week washout. This study will be conducted at the Clinical Research Center at Tufts Medical Center.
- Conditions
- Cardiovascular Disease, HIV Infection
- Being tested
- Lovaza, Placebo
- Keywords
- HIV, cardiovascular risk, atherogenic lipid profile, brachial artery reactivity, omega three fatty acids
- Medical subject headings
- Cardiovascular Diseases, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovazaDrug
Also called Omacor (omega-3-acid ethyl esters) capsules
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.
PlaceboDrug
Also called corn oil
2 capsules given twice daily
| Study group | Role | What they receive |
|---|---|---|
| Lovaza | Active comparator | Lovaza, dietary counseling Receives: Drug: Lovaza |
| Placebo | Placebo comparator | Placebo, dietary counseling Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Mean Serum Triglyceride Level at Study End
Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Serum HDL Level
Measured: 12 weeks
Brachial Artery Reactivity
To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.
Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of "% of brachial artery".
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2010
- Study completionOct 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine A Wanke, MD, Principal investigator, Tufts University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795717
- Sponsor's protocol ID
- LVZ111888
- Other IDs
- 011293-GSK Contract Reference#
- Acronym
- HALO
- Status last verified
- Aug 2019
- First submitted
- 19 Nov 2008
- Last updated
- 11 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Paranandi A, Asztalos BF, Mangili A, Kuvin J, Gerrior J, Sheehan H, Skinner SC, Tang AM, Wanke CA. Short communication: effects of omega-3 fatty acids on triglycerides and high-density lipoprotein subprofiles in HIV-infected persons with hypertriglyceridemia. AIDS Res Hum Retroviruses. 2014 Aug;30(8):800-5. doi: 10.1089/AID.2014.0005.
PubMed 24988179
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
- ClinicalTrials.gov ID
- NCT00795717
- Acronym / sponsor ID
- HALO / LVZ111888
- Conditions
- Cardiovascular Disease, HIV Infection
- Keywords
- HIV, cardiovascular risk, atherogenic lipid profile, brachial artery reactivity, omega three fatty acids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Posted 8 Dec 2014
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 determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.
Detailed description
This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, with 12-week treatment periods separated by a 4-week washout. This study will be conducted at the Clinical Research Center at Tufts Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovaza | Active comparator | Drug: LovazaLovaza, dietary counseling |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, dietary counseling |
Who may qualify
- Ages
- 18 to 65 years
- 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 previous three months and without anticipated changes in their HAART regimen throughout the duration of the study
- Fasting triglycerides > 150 mg/dl and < 1,500 mg/dl
- Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changes during the course of the study
- Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on the study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke
Key exclusion criteria (6 listed)
- Plasma HIV-1 RNA > 10,000
- Previous history of atherosclerotic disease or diabetes mellitus
- Change in HAART regimen over three months prior to study entry
- Change in lipid lowering therapy within 2 months
- On chronic anticoagulants such as heparin or coumadin
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: Omacor (omega-3-acid ethyl esters) capsulesLovaza 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. | Drug | Lovaza |
| PlaceboAlso: corn oil2 capsules given twice daily | Drug | Placebo |
Primary outcome
Change in Baseline Mean Serum Triglyceride Level at Study End
Time frame: Baseline and 12 weeks
Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo
2 secondary outcomes
Serum HDL Level
Time frame: 12 weeks
Brachial Artery Reactivity
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24988179Paranandi A, Asztalos BF, Mangili A, Kuvin J, Gerrior J, Sheehan H, Skinner SC, Tang AM, Wanke CA. Short communication: effects of omega-3 fatty acids on triglycerides and high-density lipoprotein subprofiles in HIV-infected persons with hypertriglyceridemia. AIDS Res Hum Retroviruses. 2014 Aug;30(8):800-5. doi: 10.1089/AID.2014.0005.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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 School of Medicine
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 Cardiovascular Disease 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 6 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 Sep 2019. 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. 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.
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 8 Dec 2014). 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 Baseline Mean Serum Triglyceride Level at Study End (time frame: Baseline and 12 weeks). 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 NCT00795717, 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 11 Sep 2019.