CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 129 enrolled
Drug / intervention
Lovazadrug
Likely dose
Lovaza 4g per day (each 1g capsule containing approximately 465 mg EPA and 375 mg DHA)AI-extracted
Key inclusion· 5
  • ✓HIV-infected men and women age ≥18 years
  • ✓On stable HAART for previous 2 months with no anticipated changes during study
  • ✓Fasting triglycerides 150–2,500 mg/dL
  • ✓If on lipid-lowering therapy, must be stable for 8 weeks and cannot change during study
Key exclusion· 9
  • ✕HIV-1 RNA >10,000 copies/mL
  • ✕Change in HAART regimen within 2 months prior to entry
  • ✕Change in lipid-lowering therapy within 8 weeks
  • ✕Liver enzymes >5× upper limit of normal or creatinine >1.5× upper limit of normal

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

Search/NCT01041521
NCT01041521Phase 4Completed
CompareCT.gov

The Impact of Omega Three Fatty Acids on Vascular Function in HIV

Tufts University·interventional·Posted Dec 31, 2009·Updated Feb 11, 2020

In Brief

A Phase 4 clinical trial evaluating Lovaza for High Triglyceride Level and HIV Infection. Completed, enrolled 129 participants across 1 site.

Detailed Summary

The study seeks to determine if the use of omega three fatty acids in individuals infected with HIV and with high triglycerides leads to improved triglyceride levels, better blood vessel function and decrease in the amount of obstruction in blood vessels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh Triglyceride Level, HIV Infection
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2009
Enrollment StartJan 1, 2010
Primary CompletionAug 1, 2014
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 16.5 years ago

Interventions

Lovazadrug

Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months