Heart Disease, HIV Infections
Conditions
Keywords
Omega-3 Fatty Acids, HIV, Heart Disease, Treatment experienced
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.
Interventions
DRUGLovaza
Lovaza one gram twice a day for 24 weeks
DRUGPlacebo
Placebo
Sponsors
The Campbell Foundation
Case Western Reserve University
GlaxoSmithKline
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Active infection * Inflammation or malignancy * Uncontrolled diabetes or hypothyroidism * LDL (low density lipoprotein) cholesterol \>160 and triglyceride levels \>750 * Framingham risk score \<6.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Flow Mediated Dilation (FMD) of the Brachial Artery | baseline and week 24 | 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. |
Countries
United States
Participant flow
Recruitment details
From April 22, 2009 to September 1, 2009 35 individuals were enrolled and randomized. Participants were recruited from the Special Immunology Unit at University Hospitals Case Medical Center and from other HIV clinics in Cleveland, Ohio.
Pre-assignment details
No wash out, run-in or transition period required for this study.
Participants by arm
| Arm | Count |
|---|---|
| Lovaza Lovaza 1 gram by mouth twice a day x 24 weeks | 18 |
| Placebo Placebo capsule by mouth twice a day x 24 weeks | 17 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | no baseline study performed | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Lovaza | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 18 Participants | 35 Participants |
| Age, Continuous | 51 years | 51 years | 51 years |
| Region of Enrollment United States | 17 participants | 18 participants | 35 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
Primary
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.
Time frame: baseline and week 24
Population: Randomized to have equal number in both groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lovaza | Change in Flow Mediated Dilation (FMD) of the Brachial Artery | -0.13 percent change | Standard Deviation 2.6 |
| Placebo | Change in Flow Mediated Dilation (FMD) of the Brachial Artery | 1.47 percent change | Standard Deviation 4.05 |