NCT01001767

Brief Summary

Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 9, 2012

Completed
Last Updated

January 7, 2015

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

October 22, 2009

Results QC Date

March 12, 2012

Last Update Submit

December 18, 2014

Conditions

HIV InfectionsHeart Disease

Keywords

Omega-3 Fatty AcidsHIVHeart DiseaseTreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Change in Flow Mediated Dilation (FMD) of the Brachial Artery

    Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.

    baseline and week 24

Study Arms (2)

Lovaza

ACTIVE COMPARATOR

Lovaza 1 gram by mouth twice a day for 24 weeks.

Drug: Lovaza

Placebo

PLACEBO COMPARATOR

Placebo capsule by mouth twice a day x 24 weeks.

Drug: Placebo

Interventions

LovazaDRUG

Lovaza one gram twice a day for 24 weeks

Also known as: Omega-3 fatty acid
Lovaza
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV+
  • Ages 18-70
  • HIV-1 RNA \<400 copies/ml.
  • On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos.

You may not qualify if:

  • Active infection
  • Inflammation or malignancy
  • Uncontrolled diabetes or hypothyroidism
  • LDL (low density lipoprotein) cholesterol \>160 and triglyceride levels \>750
  • Framingham risk score \<6.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Hileman CO, Carman TL, Storer NJ, Labbato DE, White CA, McComsey GA. Omega-3 fatty acids do not improve endothelial function in virologically suppressed HIV-infected men: a randomized placebo-controlled trial. AIDS Res Hum Retroviruses. 2012 Jul;28(7):649-55. doi: 10.1089/aid.2011.0088. Epub 2011 Oct 17.

    PMID: 21870979RESULT

MeSH Terms

Conditions

HIV InfectionsHeart Diseases

Interventions

OmacorFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Limitations and Caveats

Small sample size may have precluded our ability to detect a small effect. Pill counts were used to monitor adherence. All participants were male.

Results Point of Contact

Title
Grace McComsey, MC
Organization
University Hospitals Case Medical Center
mccomsey.grace@clevelandactu.org
216-844-3607

Study Officials

  • Grace McComsey, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 27, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

June 1, 2010

Last Updated

January 7, 2015

Results First Posted

April 9, 2012

Record last verified: 2014-12

Locations

US(1)