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

Completed · Phase 4 · Has a placebo group

Conditions studied: HIV Infections, AIDS, Dyslipidemia, Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT00346697

Run by

Brown, Todd, M.D., Ph.D.

People needed

48

Starts

2006-10-01

Expected to finish

2010-04-01

Last updated by the study team

2014-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Veterans Administration of Greater Los Angeles Health System — Los Angeles, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.