Atazanavir/Ritonavir and Zinc Pharmacokinetic Study
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
The study is being conducted as the most common side effect of the HIV drug atazanavir (taken
with ritonavir) is hyperbilirubinaemia. Bilirubin is a normal waste product from the body and
gets broken down in the liver so it can leave the body through the gut. Atazanavir slows the
breakdown of this chemical, which can cause jaundice (yellowing of the skin) and/or scleral
icterus (yellowing of the eyes). This is completely harmless; in fact up to 1 in 10 of the UK
population have an inherited condition that causes the same yellowing. However, some patients
don't like this side effect and it is the commonest reason for switching off the drug.
A study in people with Gilberts syndrome (the inherited condition that causes the same
changes in the chemical bilirubin) showed that a mineral supplement (zinc sulphate) reduced
the levels of bilirubin in the blood. The aim of this study is to see if using zinc
supplements can achieve the same effect in patients with high bilirubin due to atazanavir
use.