Fish Oil for HIV-Related Inflamm-aging and Immune Senescence

Completed · Not applicable · Has a placebo group

Conditions studied: HIV Infection

In brief

HIV infection is associated with premature aging of the immune system. It is believe that the persistent inflammation that accompanies HIV infection is a major contributor to premature immune aging. Fish oil has well-documented anti-inflammatory properties. In this randomized, clinical trial, we're testing whether a 12-week course of fish oil supplementation will reverse premature aging in HIV-infected older adults.

Key facts

Study ID

NCT02102724

Run by

Rush University Medical Center

People needed

37

Starts

2014-04-01

Expected to finish

2015-12-01

Last updated by the study team

2019-03-26

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• documented HIV infection
• between 40 and 70 years of age
• clinically stable HIV disease as evidenced by a CD4+ T lymphocyte count of > 250 cells/mm3
• platelet count between 150,000 and 400,000 cells/mm3 to reduce bleeding risks associated with omega 3-fatty acids
• treatment with a stable HAART regimen for at least six months prior to study entry
• plasma HIV RNA < 75 copies/ml for at least 12 months
• elevated plasma concentration of hsCRP (> 2.0 mg/L).

You may not qualify if…

• use within the past month of drugs (e.g., statins, steroids, hormones) and supplements (e.g., omega-3 fatty acids, glucosamine/chondroitin) that have anti-inflammatory effects (excluding non-regular use of aspirin or NSAIDS), or medications or supplements that affect bleeding (e.g., heparin, warfarin, clopidogrel, garlic, ginseng)
• allergy to fish or shellfish
• chronic inflammatory condition (e.g., asthma, rheumatoid arthritis), opportunistic infection or cancer, renal impairment (serum creatinine > 2.0 mg/dL), thrombocytopenia (platelet count < 150,000/mm3), bleeding episodes (e.g., gum bleeding, nosebleeds), or a metabolic condition (e.g., diabetes mellitus, thyroid disease)
• body mass index of > 35, since obesity is associated with inflammation
• impaired liver function as evidenced by liver enzyme elevations > three times the upper limit of normal (AST or ALT > 150 IU/L)
• history of prostate cancer
• LDL cholesterol level > 120 mg/dL
• lifestyle exclusion factors include use of illicit drugs and consumption of > 3 alcoholic drinks/day

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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