The Effect of Hyperbilirubinemia on CV Disease, Neurocog Function and Renal Function (SSAT044)
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|ClinicalTrials.gov Identifier: NCT01475240|
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : April 11, 2014
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 impairment.
The purpose of this study is to evaluate the impact of hyperbilirubinemia (HBR) on risk of heart and renal diseases, and cognitive function.
|Condition or disease|
Use of some protease inhibitors is associated with unconjugated hyperbilirubinemia as a result of inhibition of the UGT1A1 enzyme.
Elevated levels of unconjugated bilirubin are best characterized among individuals with Gilbert syndrome, which is the most common inherited cause of unconjugated hyperbilirubinemia, present in 3-10% of the general population. Gilbert syndrome arises through variants in the UGT1A1 enzyme, thus these PIs induce a biochemical picture similar to Gilbert syndrome. Although elevations of bilirubin may occasionally lead to scleral icterus or jaundice, cohort studies of individuals with Gilbert syndrome indicate bilirubin elevations may have antioxidant and anti-inflammatory properties and are associated with reduced risk of cardiovascular events.
Inflammation may also be relevant to cardiovascular (CV) risk, neurocognitive impairment and renal disease in HIV infection. This study seeks to investigate any association between antiretroviral associated HBR and CV risk markers, neurocognitive impairment and renal dysfunction
|Study Type :||Observational|
|Actual Enrollment :||101 participants|
|Observational Model:||Case Control|
|Official 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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Group 1: Controls
HIV-infected patients on stable > 6 months on TDF/FTC or ABC/3TC plus PI/r based ARV regimen with normal bilirubin
Group 2: Cases
HIV-infected patients on stable >6 months on TDF/FTC or ABC/3TC plus PI/r based ARV regimen with HBR (>2.5 X upper limit)
- To evaluate the impact of hyperbilirubinemia on markers of cardiovascular disease [ Time Frame: 1 year ]Assessment of Pulse Wave Velocity; Carotid intimal thickness; Vascular markers (iCAM, vCAM); Lipid fractions and sub fractions
- To evaluate the impact of hyperbilirubinemia on neurocognitive function and renal markers [ Time Frame: 1 year ]Assment of Neurocognitive testing; IL-6, d-dimer, uric acid, and hs-CRP; Urinary protein / creatinine ratio; Urinary Retinal binding / protein ratio
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475240
|St Stephen's AIDS Trust|
|London, United Kingdom, SW10 9NH|
|Principal Investigator:||Graeme Moyle, Dr||St Stephen's AIDS Trust|