Status:
COMPLETED
Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients
Lead Sponsor:
Brown, Todd, M.D., Ph.D.
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
GlaxoSmithKline
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 o...
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 hypert...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00346697
Start Date
October 1 2006
End Date
April 1 2010
Last Update
November 5 2014
Active Locations (3)
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1
Veterans Administration of Greater Los Angeles Health System
Los Angeles, California, United States, 90073
2
Georgetown University
Washington D.C., District of Columbia, United States, 20007
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287