The Effect of Hyperbilirubinemia on CV Disease, Neurocog Function and Renal Function

NCT01475240 | Completed

• 1 other identifier: SSAT 044
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of hyperbilirubinemia on markers of cardiovascular disease

  Assessment of Pulse Wave Velocity; Carotid intimal thickness; Vascular markers (iCAM, vCAM); Lipid fractions and sub fractions

  1 year

Secondary Outcomes (1)

• To evaluate the impact of hyperbilirubinemia on neurocognitive function and renal markers

  1 year

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV-infected males/females aged 18 years and above

You may qualify if:

• 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.

You may not qualify if:

• Grade 1-2 Bilirubin
• Known CV disease (angina, coronary artery disease, peripheral vascular disease, stroke, congestive cardiac failure or myocardial dysfunction), Diabetes Mellitus, antihypertensive therapy
• Chronic NSAID use including low dose aspirin
• Known renal or CNS or neurocognitive disease
• HIV RNA \>400copies/ml in last 6 months
• Change of antiretroviral Therapy in last 6 months
• 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.

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

St Stephen's AIDS Trust

London, SW10 9NH, United Kingdom

Location

Study Officials

• Graeme Moyle, Dr

  St Stephen's AIDS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 21, 2011
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 11, 2014

Record last verified: 2014-04

Locations

GB (1)