Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections AIDS Dyslipidemia Hypertriglyceridemia |
Drug: Omega-3 fatty acid administration |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of N-3 Fatty Acid on Plasma Triglyceride Levels in Hypertriglyceridemic HIV Patients Receiving Highly Active Antiretroviral Therapy |
- Change in triglyceride concentrations from baseline in the LOVAZA group compared to the placebo group. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Total cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- LDL cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- HDL-cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Markers of systemic inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Markers of insulin resistance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- HIV-disease control (CD4+ counts, HIV viral loads) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Measures of hepatotoxicity (ALT) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Platelet function [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | June 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LOVAZA
4 g/d of omega-3 fatty acid esters, plus dietary counseling
|
Drug: Omega-3 fatty acid administration
LOVAZA 1 gram capsules, 4 capsules daily
|
|
Placebo Comparator: Placebo
Corn oil placebo, plus dietary counselling
|
Drug: Omega-3 fatty acid administration
LOVAZA 1 gram capsules, 4 capsules daily
|
Detailed Description:
Hypertriglyceridemia is common among HIV-infected patients receiving Highly Active Antiretroviral Therapy (HAART). Although fibrates, statins, and niacin have all been used in the management of hypertriglyceridemia in HIV-infected patients, optimal control is difficult to achieve and other agents are needed. Omega-3 fatty acids are effective for lowering triglycerides in patients without HIV infection, but experience in HIV-infected patients is limited. In addition, omega-3 fatty acids may also have secondary benefits in decreasing bone resorption and decreasing markers of systemic inflammation. The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation. It is 8- week randomized, double-blind trial of omega-3 fatty acids (LOVAZA, GSK, Inc) compared to placebo in 48 HAART-treated HIV-infected patients with triglycerides between 250 and 1000 mg/dl receiving dietary counseling. Subjects will be recruited from three centers (Johns Hopkins, Georgetown, and Los Angeles VAMC). The primary endpoint will be the change in triglyceride concentrations from baseline in the LOVAZA group compared to the placebo group. Secondary endpoints include the effect of LOVAZA on other lipid targets (total cholesterol, LDL cholesterol, HDL-cholesterol), markers of systemic inflammation, markers of bone turnover, markers of insulin resistance, HIV-disease control (CD4+ counts, HIV viral loads), measures of hepatotoxicity (ALT), platelet function, and patient reports of adverse events. Omega-3 fatty acids may be a useful adjunct in the treatment of hypertriglyceridemia in HIV-infected patients, but additional controlled studies are needed to assess its safety and efficacy using a purified, standardized preparation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability and willingness to give informed consent
- Age ≥ 18 years
- HIV-1 infection documented at any time prior to study entry
- Fasting plasma triglyceride value between 200 and 1000 mg/dL on two occasions within 4 weeks
- Subjects must be receiving a stable antiretroviral medication regimen for > 3 months without any anticipated changes during the study interval
- Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception
- On stable lipid modification pharmacotherapy for at least 8 weeks prior to study entry
Exclusion Criteria
- Hemoglobin A1C > 8.5 %
- Uncontrolled hypothyroidism (TSH > 4.5)
- HIV viral load > 5,000 copies/ml (cpm),
- Active liver disease and/or liver transaminases greater than 2.0 X upper limit of normal
- Active kidney disease or serum creatinine > 2.5 mg/dL
- Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure
- Uncontrolled hypertension within 4 weeks of study entry (SBP > 180 mmHg or DBP > 100 mmHg)
- Use of systemic cancer chemotherapy within 8 weeks of study entry
- Pregnancy or breastfeeding
- Drug or alcohol dependence, or other conditions which may affect study compliance
- History of coagulopathy or use of anticoagulants such as warfarin
- Use of omega-3 fatty acid preparation in the 12 weeks prior to randomization
- Significant changes in clinical status from the Screening Visit which would preclude the patient from being an appropriate candidate.
- Any of the following laboratory parameters: hematocrit < 25%, absolute neutrophil count < 1.5 x 10^9/L, platelets < 100 x 10^9/L or hemoglobin < 8.0 gm/dL
Contacts and Locations| Contact: Todd T. Brown, MD | 410-955-2130 | tbrown27@jhmi.edu |
| United States, California | |
| Veterans Administration of Greater Los Angeles Health System | Active, not recruiting |
| Los Angeles, California, United States, 90073 | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Joseph Timpone, MD 202-687-6845 timponej@gunet.georgetown.edu | |
| United States, Maryland | |
| Johns Hopkins University | Active, not recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: | Todd T. Brown, MD | Johns Hopkins University |
| Principal Investigator: | David Leaf, MD | Veterans Adminstration of Greater Los Angeles Health System |
| Principal Investigator: | Mattew Goetz, MD | Veterans Adminstration of Greater Los Angeles Health System |
| Principal Investigator: | Adrian S Dobs, MD | Johns Hopkins University |
| Principal Investigator: | Joseph Timpone, MD | Georgetown University |
More Information
No publications provided
| Responsible Party: | Todd T. Brown, MD, PhD, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00346697 History of Changes |
| Other Study ID Numbers: | K23 AT002862-01, K23AT002862-01 |
| Study First Received: | June 29, 2006 |
| Last Updated: | February 16, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Brown, Todd, M.D., Ph.D.:
|
AIDS HIV HAART Lipids Triglycerides |
Cholesterol omega-3 fatty acids bone turnover inflammation insulin resistance |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Hypertriglyceridemia Dyslipidemias Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2013
