NCT00598910

Brief Summary

Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2007

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 30, 2009

Status Verified

March 1, 2009

Enrollment Period

1.1 years

First QC Date

January 11, 2008

Last Update Submit

March 27, 2009

Conditions

Hyper-Triglyceridemia

Keywords

HIV infection

Outcome Measures

Primary Outcomes (1)

  • Percent change in serum triglycerides from baseline to treatment endpoint versus placebo

    12 weeks treatment

Secondary Outcomes (3)

  • Absolute change in serum triglycerides

    12 weeks

  • Absolute and percent change in cholesterol and cholesterol subfractions

    12 weeks

  • Absolute and percent change in apolipoprotein A and B

    12 weeks

Study Arms (2)

A

EXPERIMENTAL
Drug: Omacor

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OmacorDRUG

n-3 PUFA

A
PlaceboDRUG

Placebo

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Triglycerides between 200 and 800
  • diagnosed HIV infection
  • following HAART therapy

You may not qualify if:

  • other malignant disease
  • not compliant
  • allergy against fish oil
  • soy or olive oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Site 2

Bochum, Germany

Location

Site 1

Hanover, Germany

Location

Site 3

London, United Kingdom

Location

Site 4

London, United Kingdom

Location

Site 5

London, United Kingdom

Location

Related Publications (1)

  • Peters BS, Wierzbicki AS, Moyle G, Nair D, Brockmeyer N. The effect of a 12-week course of omega-3 polyunsaturated fatty acids on lipid parameters in hypertriglyceridemic adult HIV-infected patients undergoing HAART: a randomized, placebo-controlled pilot trial. Clin Ther. 2012 Jan;34(1):67-76. doi: 10.1016/j.clinthera.2011.12.001. Epub 2011 Dec 31.

    PMID: 22212377DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Omacor

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 23, 2008

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

March 1, 2009

Last Updated

March 30, 2009

Record last verified: 2009-03

Locations

DE(2)GB(3)