Use of some protease inhibitors is associated with elevations of a blood pigment called
bilirubin. This may occasionally lead to yellowing of the eyes (scleral icterus) or jaundice,
but in the general population bilirubin elevations have been shown to have antioxidant and
anti-inflammatory properties that could be associated with reduced risk of cardiovascular or
other disease events.
Inflammation may also be relevant to neurocognitive impairment in HIV (Human Immunodeficiency
Virus) infection hence elevations of bilirubin may also be protective against neurocognitive
The purpose of this study is to evaluate the impact of hyperbilirubinemia (HBR) on risk of
heart and renal diseases, and cognitive function.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01475240
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements.
Documented HIV-1 infection.
>18 years of age
Stable on PI based therapy with TDF/FTC or ABC/3TC > 6 months with either normal bilirubin or bilirubin >2.5 X upper limit
Stable for > 3 months on lipid lowering therapy, anticoagulant, hormone supplements, metformin (for lipohypertrophy) or other metabolic therapies
No known or past history of cardiovascular disease, neurocognitive disorder or renal disease.
Active Hepatitis B (sAg +ve) or hepatitis C (detectable HCV RNA,, treated or cleared Hepatitis C permitted if infection and/or treatment > 6months previous)
Use of anabolic steroids. Cutaneous administered testosterone supplements stable for
>3 months for documented hypogonadism permitted. Oral contraceptives stable for 3 months permitted.
All locations for NCT01475240
United Kingdom (1)
St Stephen's AIDS Trust
London, United Kingdom, SW10 9NH
View full eligibility
Tris trial is registered with FDA with number: NCT01475240. The sponsor of the trial is St Stephens Aids Trust and it is looking for 101 volunteers for the current phase.
Official trial title: A Cross-sectional Controlled Study to Evaluate the Impact of Hyperbilirubinemia on Markers of Cardiovascular Disease, Neurocognitive Function and Renal Markers in HIV-1 Infected Subjects on Protease Inhibitors
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