Trial Outcomes & Findings for Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients (NCT NCT00346697)

NCT ID: NCT00346697

Last Updated: 2014-11-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 48 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2014-11-05

Participant Flow

Recruitment took plave between November 2006 and September 2010 at 3 sites (Johns Hopkins University, Baltimore, MD;Veteran's Administration Greater Los Angeles Healthcare System (Los Angeles, CA), and the Georgetown University Hospital (Washington, DC). Participants were recruited from the HIV Clinics at these institutions.

Participant milestones

Measure	LOVAZA 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo Corn oil placebo, plus dietary counselling
Overall Study STARTED	24	24
Overall Study COMPLETED	24	23
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	LOVAZA 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo Corn oil placebo, plus dietary counselling
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients

Baseline characteristics by cohort

Measure	LOVAZA n=24 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=24 Participants Corn oil placebo, plus dietary counselling	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants	48 years n=7 Participants	49.5 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	LOVAZA n=24 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=23 Participants Corn oil placebo, plus dietary counselling
Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-34 mg/dl Interval -149.0 to 9.5	40 mg/dl Interval -51.0 to 123.0

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	LOVAZA n=24 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=23 Participants Corn oil placebo, plus dietary counselling
Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group	-16 mg/dl Interval -31.0 to 23.0	-5 mg/dl Interval -25.0 to 19.0

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	LOVAZA n=24 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=23 Participants Corn oil placebo, plus dietary counselling
Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group	-12.5 mg/dl Interval -30.0 to 17.0	-9 mg/dl Interval -23.0 to 21.0

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	LOVAZA n=24 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=23 Participants Corn oil placebo, plus dietary counselling
Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group	1.5 mg/dl Interval -2.0 to 4.0	-1 mg/dl Interval -6.0 to 3.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=23 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=22 Participants Corn oil placebo, plus dietary counselling
Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group	0.56 units on a scale Interval -0.51 to 3.6	0.94 units on a scale Interval -1.9 to 4.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=21 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=21 Participants Corn oil placebo, plus dietary counselling
Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group	20 cells/cc Interval -28.0 to 107.0	7 cells/cc Interval -42.0 to 118.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=23 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=22 Participants Corn oil placebo, plus dietary counselling
Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.04 ng/ml Interval -1.19 to 0.35	0.17 ng/ml Interval -0.38 to 0.99

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=23 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=22 Participants Corn oil placebo, plus dietary counselling
Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.62 pg/mL Interval -1.89 to 0.13	0.19 pg/mL Interval -0.13 to 1.65

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=23 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=22 Participants Corn oil placebo, plus dietary counselling
Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.36 pg/mL Interval -2.27 to 0.014	0.58 pg/mL Interval -1.15 to 2.25

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=23 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=22 Participants Corn oil placebo, plus dietary counselling
Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.90 pg/mL Interval -91.8 to 69.8	-66.3 pg/mL Interval -189.0 to 152.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=23 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=22 Participants Corn oil placebo, plus dietary counselling
Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-63.5 pg/mL Interval -371.0 to 615.0	118 pg/mL Interval -499.0 to 565.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=23 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=22 Participants Corn oil placebo, plus dietary counselling
Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.02 ng/mL Interval -0.08 to 0.02	0.03 ng/mL Interval -0.06 to 0.09

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=23 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=22 Participants Corn oil placebo, plus dietary counselling
Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-5.23 mcg/L Interval -12.6 to -0.16	-2.12 mcg/L Interval -8.7 to 1.3

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=18 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=16 Participants Corn oil placebo, plus dietary counselling
Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.	6.5 seconds Interval -3.0 to 21.0	-6 seconds Interval -13.0 to 9.5

SECONDARY outcome

Timeframe: 8 weeks

Population: Analysis done on all participants with available data

Outcome measures

Measure	LOVAZA n=18 Participants 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Placebo n=16 Participants Corn oil placebo, plus dietary counselling
Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.	5.5 seconds Interval -6.0 to 39.0	-18 seconds Interval -46.5 to 28.0

Adverse Events

LOVAZA

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LOVAZA n=24 participants at risk 4 g/d of omega-3 fatty acid esters, plus dietary counseling Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily	Placebo n=24 participants at risk Corn oil placebo, plus dietary counselling Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily
Gastrointestinal disorders Gastrointesitnal Side effects (dyspepsia, bloating, fishy taste)	12.5% 3/24 • Number of events 3	25.0% 6/24 • Number of events 6
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • Number of events 1	8.3% 2/24 • Number of events 2

Additional Information

Dr Todd Brown, Associate Professor of Medicine and Epidemiology

Johns Hopkins University

Phone: 410-502-2327

Email: tbrown27@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place