Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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 of omega-3 fatty acid administration of markers of bone turnover and inflammation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown, Todd, M.D., Ph.D.
• Collaborators: GlaxoSmithKline; National Center for Complementary and Integrative Health (NCCIH)

Criteria

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