Phase 4 N=48 Randomized Quadruple-blind Treatment

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

HIV Infections · AIDS · Dyslipidemia · Hypertriglyceridemia

Bottom Line

View on ClinicalTrials.gov: NCT00346697 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. — -34; 40 mg/dl — p=0.01

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Omega-3 fatty acid administration (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brown, Todd, M.D., Ph.D.
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-34; 40	0.01 sig
SECONDARY Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group	-16; -5	.80
SECONDARY Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group	-12.5; -9	0.72
SECONDARY Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group	1.5; -1	0.16
SECONDARY Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group	0.56; 0.94	0.96
SECONDARY Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group	20; 7	0.70
SECONDARY Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.04; 0.17	0.20
SECONDARY Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.62; 0.19	0.006 sig
SECONDARY Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.36; 0.58	0.04 sig
SECONDARY Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.90; -66.3	0.89
SECONDARY Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-63.5; 118	0.89
SECONDARY Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-0.02; 0.03	0.25
SECONDARY Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.	-5.23; -2.12	0.14
SECONDARY Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.	6.5; -6	0.12
SECONDARY Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.	5.5; -18	0.30

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00346697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.