Human Immunodeficiency VirusPhase 4NCT00296153
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment
A Phase 4 study testing Omega-3-acid ethyl esters 90 in people with Human Immunodeficiency Virus and Ischemic Heart Disease, run by Pronova BioPharma at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Ischemic Heart Disease
- What is being tested?
- Omega-3-acid ethyl esters 90
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Oct 2007
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man/women > 18 years of age
- Documented HIV infection
- On active treatment with HAART for at least 3 months.
- Written informed consent. This implies that the patient can read and understand Danish or English
Who cannot join
- Age < 18 years
- Malign disease
- Patients assessed as not cooperative
- Patients planning to be pregnant or who are already pregnant or breast feeding.
- Patients who have been taking fish oil capsules prior to randomization. However, patients who have discontinued fish oil supplements at least 8 weeks prior to the first visit will be included
- Patients allergic to fish proteins
- Statin treatment that has been ongoing for less than three months, or a change in statin treatment dose within the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omacor; Omega-3-Acid Ethyl Ester 90 (n-3 PUFA) and Risk Factors in HIV Infected Patients Treated With HAART, With Special Focus on Lipids
The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART)
Read the detailed description
Results from recent studies show increasing numbers of Ischemic Heart Disease (IHD) incidents among patients on HAART treatment (Highly Active Antiviral Therapy). Three elements have received special attention:
- the immunodeficient effects of the HIV infection itself may influence the progression of arteriosclerosis
- the higher levels of risk behaviour in this group of patients (i.e. high prevalence of smokers in this group)
- The HAART treatment itself increases plasma levels of cholesterol, LDL cholesterol and triglycerides, resulting in HIV related lipodystrophy.
The cardioprotective effects of n-3 PUFAs are well established both through epidemiological studies and through small and large clinical trials. Clinical trials have shown positive effects of n-3 PUFA on plasma triglycerides, and statistically significant reductions in cardiovascular death and sudden cardiac death. Moreover n-3 PUFAs have been shown to have beneficial effects on endothelial function. Based on the above rationale it is expected that Omacor (Omega-3-acid ethyl ester 90) will have positive effects on risk factors related to Ischemic Heart Disease in HIV patients on HAART treatment.
Approximately 50 patients will be randomized to Omacor 4 grams/day or placebo. Treatment period is 12 weeks.
- Being tested
- Omega-3-acid ethyl esters 90
- Keywords
- Human immunodeficiency Virus (HIV), Highly Active Antiviral Therapy (HAART), Ischemic Heart Disease, OMACOR, Triglycerides, Endothelial function, Treatment Experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3-acid ethyl esters 90Drug
Also called Omacor versus placebo
Omacor capsule 1000mg x 4 per day. Duration 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Omacor 1000mg x 4 / day Receives: Drug: Omega-3-acid ethyl esters 90 |
| 2 | Placebo comparator | Not described Receives: Drug: Omega-3-acid ethyl esters 90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from week 0 (baseline) to week 12 for: Plasma triglycerides
Measured: baseline and 12 weeks
Secondary outcomes (5)
The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation
Measured: baseline and 12 weeks
HDL-cholesterol, LDL-cholesterol, total cholesterol
Measured: baseline and 12 weeks
Inflammatory parameters: ICAM, VCAM, sensitive CRP
Measured: baseline and 12 weeks
Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Factor, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes
Measured: baseline and 12 weeks
Safety parameters
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aalborg University Hospital
- Investigators
- Jeppe H. Christensen, PhD, Principal investigator, Aalborg Hospital, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296153
- Sponsor's protocol ID
- CTN K85 05026
- Other IDs
- Eudract no: 2005-005135-10
- Status last verified
- Mar 2008
- First submitted
- 23 Feb 2006
- Last updated
- 11 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omacor; Omega-3-Acid Ethyl Ester 90 (n-3 PUFA) and Risk Factors in HIV Infected Patients Treated With HAART, With Special Focus on Lipids
- ClinicalTrials.gov ID
- NCT00296153
- Acronym / sponsor ID
- CTN K85 05026
- Keywords
- Human immunodeficiency Virus (HIV), Highly Active Antiviral Therapy (HAART), Ischemic Heart Disease, OMACOR, Triglycerides, Endothelial function, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Pronova BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Aalborg University Hospital
- Study start
- Feb 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 24 Feb 2006 (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.
The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART)
Detailed description
Results from recent studies show increasing numbers of Ischemic Heart Disease (IHD) incidents among patients on HAART treatment (Highly Active Antiviral Therapy). Three elements have received special attention:
- the immunodeficient effects of the HIV infection itself may influence the progression of arteriosclerosis
- the higher levels of risk behaviour in this group of patients (i.e. high prevalence of smokers in this group)
- The HAART treatment itself increases plasma levels of cholesterol, LDL cholesterol and triglycerides, resulting in HIV related lipodystrophy.
The cardioprotective effects of n-3 PUFAs are well established both through epidemiological studies and through small and large clinical trials. Clinical trials have shown positive effects of n-3 PUFA on plasma triglycerides, and statistically significant reductions in cardiovascular death and sudden cardiac death. Moreover n-3 PUFAs have been shown to have beneficial effects on endothelial function. Based on the above rationale it is expected that Omacor (Omega-3-acid ethyl ester 90) will have positive effects on risk factors related to Ischemic Heart Disease in HIV patients on HAART treatment.
Approximately 50 patients will be randomized to Omacor 4 grams/day or placebo. Treatment period is 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Omega-3-acid ethyl esters 90Omacor 1000mg x 4 / day |
| 2 | Placebo comparator | Drug: Omega-3-acid ethyl esters 90 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man/women > 18 years of age
- Documented HIV infection
- On active treatment with HAART for at least 3 months.
- Written informed consent. This implies that the patient can read and understand Danish or English
Key exclusion criteria (7 listed)
- Age < 18 years
- Malign disease
- Patients assessed as not cooperative
- Patients planning to be pregnant or who are already pregnant or breast feeding.
- Patients who have been taking fish oil capsules prior to randomization. However, patients who have discontinued fish oil supplements at least 8 weeks prior to the first visit will be included
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 |
|---|---|---|
| Omega-3-acid ethyl esters 90Also: Omacor versus placeboOmacor capsule 1000mg x 4 per day. Duration 12 weeks | Drug | 1, 2 |
Primary outcome
The change from week 0 (baseline) to week 12 for: Plasma triglycerides
Time frame: baseline and 12 weeks
5 secondary outcomes
The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation
Time frame: baseline and 12 weeks
HDL-cholesterol, LDL-cholesterol, total cholesterol
Time frame: baseline and 12 weeks
Inflammatory parameters: ICAM, VCAM, sensitive CRP
Time frame: baseline and 12 weeks
Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Factor, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes
Time frame: baseline and 12 weeks
Safety parameters
Time frame: baseline and 12 weeks
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 11 Mar 2008.
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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.
Jeppe H. Christensen, PhD principal investigator
Aalborg Hospital, Department of Nephrology
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 Omega-3-acid ethyl esters 90 in people with Human Immunodeficiency Virus and Ischemic Heart Disease, run by Pronova BioPharma at 1 site in Denmark.
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 4 inclusion and 7 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 Mar 2008. 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 Denmark. 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?
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?
The change from week 0 (baseline) to week 12 for: Plasma triglycerides (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?
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 Mar 2008.