Status:
COMPLETED
The Effect of Hyperbilirubinemia on CV Disease, Neurocog Function and Renal Function
Lead Sponsor:
St Stephens Aids Trust
Conditions:
HIV
Eligibility:
All Genders
18+ years
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...
Detailed Description
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 amo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01475240
Start Date
January 1 2012
End Date
November 1 2013
Last Update
April 11 2014
Active Locations (1)
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1
St Stephen's AIDS Trust
London, United Kingdom, SW10 9NH