CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Omega-3 fatty acid administration +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00346697
NCT00346697Phase 4Completed
CompareCT.gov

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

Brown, Todd, M.D., Ph.D.·interventional·Posted Jun 30, 2006·Updated Nov 5, 2014

In Brief

A Phase 4 clinical trial evaluating Omega-3 fatty acid administration and Placebo for HIV Infections and 3 related conditions. Completed, enrolled 48 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, AIDS, Dyslipidemia, Hypertriglyceridemia
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH), GlaxoSmithKline

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2006
Enrollment StartOct 1, 2006
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.0 years ago

Interventions

Omega-3 fatty acid administrationdrug

LOVAZA 1 gram capsules, 4 capsules daily

Placebodrug

Corn-oil placebo