Phase 4
Completed N=117
The Impact of Omega Three Fatty Acids on Vascular Function in HIV
High Triglyceride Level · HIV
Source: ClinicalTrials.gov NCT01041521 ↗
Enrolled (actual)
117
Serious AEs
36.8%
Results posted
Feb 2020
Primary outcomePrimary: Triglyceride Level — 130; 159 mg/dL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Triglyceride Level |
130; 159 | — |
| SECONDARY Vascular Function |
833; 832 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-infected men and women at least 18 years of age,
- On stable HAART for the previous two months and without anticipated changes in their HAART regimen throughout the duration of the study,
- Fasting triglycerides > 150 mg/dl and 1 year.
- Ability to provide consent.
Exclusion Criteria
- plasma HIV-1 RNA > 10,000 copies/ml
- change in HAART regimen over two months prior to study entry
- change in lipid lowering therapy within 2 months (8 weeks)
- Pregnancy in female participants
- Evidence of liver or renal disease with values of liver enzymes > 5 X upper limit of normal or creatinine > 1.5 X upper limit of normal
- presence of active opportunistic infection or malignancy
- presence of other inflammatory or end organ disease (, rheumatoid arthritis, active treatment for hepatitis c, or other diseases that may alter inflammatory markers)
- routine ingestion of fish oil (individuals who have used fish oil would be reconsidered for study participation if they discontinue use of fish oil for 8 weeks and TG levels remain elevated).
- Allergic to fish or Lovaza
- BMI >35
Data sourced from ClinicalTrials.gov (NCT01041521). 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. Informational only — not medical advice.