Omacor and Cardiovascular Risk Factors in HIV Patients on... | NCT00296153

Studies
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

NCT00296153

Sponsor

Pronova BioPharma

Status

Completed

Last Update Posted

Mar 11, 2008Estimated

Enrollment

51Actual

Phase

Phase 4

Conditions

Human Immunodeficiency Virus
Ischemic Heart Disease

Interventions

Omega-3-acid ethyl esters 90

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Eudract no: 2005-005135-10

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Oct 2007Actual

First Submitted Date

Feb 23, 2006

First Submission Date that Met QC Criteria

Feb 23, 2006

First Posted Date

Feb 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2008

Last Update Posted Date

Mar 11, 2008Estimated

Name	Class
Aalborg University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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)

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Omacor 1000mg x 4 / day	Drug: Omega-3-acid ethyl esters 90
2	Placebo Comparator		Drug: Omega-3-acid ethyl esters 90

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3-acid ethyl esters 90	Drug	Omacor capsule 1000mg x 4 per day. Duration 12 weeks	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change from week 0 (baseline) to week 12 for: Plasma triglycerides		baseline and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation		baseline and 12 weeks
HDL-cholesterol, LDL-cholesterol, total cholesterol		baseline and 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeppe H. Christensen, PhD	Aalborg Hospital, Department of Nephrology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg Hospital, Department of Nephrology		Aalborg		9100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

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Browse Branches

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