Trial Outcomes & Findings for Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial (NCT NCT00795717)

NCT ID: NCT00795717

Last Updated: 2019-09-11

Results Overview

Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2019-09-11

Participant Flow

Phone contact n=109 Screening n=51 Eligible n=42 Screen failed n=9 Declined participation n=1 Randomized to treatment first n=20 Randomized to placebo first n=21

Participant milestones

Participant milestones
Measure	Lovaza Then Placebo Lovaza, dietary counseling Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks vs. placebo 2 capsules given twice daily.	Placebo Then Lovaza Placebo, dietary counseling Placebo : 2 capsules given twice daily vs. Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks
Phase I Followed by Wash Out x 4 Weeks STARTED	20	21
Phase I Followed by Wash Out x 4 Weeks COMPLETED	18	19
Phase I Followed by Wash Out x 4 Weeks NOT COMPLETED	2	2
Phase II STARTED	18	19
Phase II COMPLETED	18	18
Phase II NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Lovaza Then Placebo Lovaza, dietary counseling Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks vs. placebo 2 capsules given twice daily.	Placebo Then Lovaza Placebo, dietary counseling Placebo : 2 capsules given twice daily vs. Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks
Phase I Followed by Wash Out x 4 Weeks alcohol treatment	1	0
Phase I Followed by Wash Out x 4 Weeks Adverse Event	1	1
Phase I Followed by Wash Out x 4 Weeks Lost to Follow-up	0	1
Phase II too busy	0	1

Baseline Characteristics

Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lovaza Then Placebo n=20 Participants Lovaza, dietary counseling Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.	Placebo Then Lovaza n=21 Participants Placebo or Corn oil pill, dietary counseling Corn oil pill : 2 capsules given twice daily for 12 weeks	Total n=41 Participants Total of all reporting groups
Age, Continuous	51.5 years n=39 Participants	55.0 years n=41 Participants	52.0 years n=35 Participants
Sex: Female, Male Female	3 Participants n=39 Participants	3 Participants n=41 Participants	6 Participants n=35 Participants
Sex: Female, Male Male	17 Participants n=39 Participants	18 Participants n=41 Participants	35 Participants n=35 Participants
Region of Enrollment United States	20 participants n=39 Participants	21 participants n=41 Participants	41 participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Randomized, cross over design

Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo

Outcome measures

Outcome measures
Measure	Lovaza n=39 Participants Lovaza, dietary counseling Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.	Placebo n=39 Participants Corn oil, dietary counseling Corn oil : 2 capsules given twice daily
Change in Baseline Mean Serum Triglyceride Level at Study End	-103.0 mg/dl Standard Deviation 92.2	-23.4 mg/dl Standard Deviation 60.8

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Lovaza n=39 Participants Lovaza, dietary counseling Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.	Placebo n=39 Participants Corn oil, dietary counseling Corn oil : 2 capsules given twice daily
Serum HDL Level	39 mg/dl Standard Deviation 12	36 mg/dl Standard Deviation 10

SECONDARY outcome

Timeframe: 12 weeks

To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks. Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of "% of brachial artery".

Outcome measures

Outcome measures
Measure	Lovaza n=39 Participants Lovaza, dietary counseling Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.	Placebo n=39 Participants Corn oil, dietary counseling Corn oil : 2 capsules given twice daily
Brachial Artery Reactivity	6.4 % of brachial artery diameter Standard Deviation 5.9	7.5 % of brachial artery diameter Standard Deviation 3.1

Adverse Events

Lovaza-Active

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Christine A. Wanke, MD

Tufts University School of Medicine

Phone: 617-636-3811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Lovaza-Active n=41 participants at risk Lovaza, dietary counseling	Placebo n=41 participants at risk Placebo, dietary counseling
Gastrointestinal disorders loose stool	9.8% 4/41 • Number of events 4 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders flatulence	7.3% 3/41 • Number of events 3 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Respiratory, thoracic and mediastinal disorders sore throat	4.9% 2/41 • Number of events 2 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Respiratory, thoracic and mediastinal disorders cold	4.9% 2/41 • Number of events 2 • AE reporting lasted the duration of the study (28 weeks)	9.8% 4/41 • Number of events 4 • AE reporting lasted the duration of the study (28 weeks)
Musculoskeletal and connective tissue disorders arthritis	4.9% 2/41 • Number of events 2 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders early satiety	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders gastroenteritis	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	4.9% 2/41 • Number of events 2 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders hemorrhoids	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders hiccups	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Renal and urinary disorders renal stone	4.9% 2/41 • Number of events 2 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders worsening diarrhea	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders fish burps	4.9% 2/41 • Number of events 2 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Nervous system disorders lightheadedness	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Respiratory, thoracic and mediastinal disorders sinusitis	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	7.3% 3/41 • Number of events 3 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders GI blockage	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders nausea	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Cardiac disorders hypertension	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Respiratory, thoracic and mediastinal disorders shortness of breath	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Renal and urinary disorders urinary tract infection	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)
Skin and subcutaneous tissue disorders dry skin	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	4.9% 2/41 • Number of events 2 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders fish taste	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	4.9% 2/41 • Number of events 2 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders anal polyp surgery	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Psychiatric disorders depression	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders heart burn	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Skin and subcutaneous tissue disorders rash	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Gastrointestinal disorders oral thrush	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Cardiac disorders enlarged aorta	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Metabolism and nutrition disorders weight gain	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Reproductive system and breast disorders testosterone insufficiency	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Nervous system disorders insomnia	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Skin and subcutaneous tissue disorders nodule under chest	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Cardiac disorders nodule right carotid	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)
Surgical and medical procedures knee replacement	0.00% 0/41 • AE reporting lasted the duration of the study (28 weeks)	2.4% 1/41 • Number of events 1 • AE reporting lasted the duration of the study (28 weeks)