- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795717
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial (HALO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV-infected men and women at least 18 years of age
- On stable HAART for previous three months and without anticipated changes in their HAART regimen throughout the duration of the study
- Fasting triglycerides > 150 mg/dl and < 1,500 mg/dl
- Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changes during the course of the study
- Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on the study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke
- Female participants of reproductive age must not be pregnant (negative test) or lactating at screening and throughout the trial and agree to use 2 methods of barrier contraception for the course of the trial and 2 months after the trial unless they are surgically sterilized (tubal ligation or hysterectomy), or post-menopausal with no menses for > 1 year
- Ability to provide consent
Exclusion Criteria:
- Plasma HIV-1 RNA > 10,000
- Previous history of atherosclerotic disease or diabetes mellitus
- Change in HAART regimen over three months prior to study entry
- Change in lipid lowering therapy within 2 months
- On chronic anticoagulants such as heparin or coumadin
- On fish oil, omega 3 supplements, or Omacor currently or during the past month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lovaza
Lovaza, dietary counseling
|
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.
Other Names:
|
Placebo Comparator: Placebo
Placebo, dietary counseling
|
2 capsules given twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Baseline Mean Serum Triglyceride Level at Study End
Time Frame: Baseline and 12 weeks
|
Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum HDL Level
Time Frame: 12 weeks
|
12 weeks
|
|
Brachial Artery Reactivity
Time Frame: 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". |
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine A Wanke, MD, Tufts University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Cardiovascular Diseases
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- LVZ111888
- 011293-GSK Contract Reference#
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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