SSAT 043 Atazanavir/ritonavir and zinc pharmacokinetic study

• Research type

  Research Study

• Full title

  A randomized crossover study of the effects of zinc sulphate supplementation on atazanavir/ritonavir-associated hyperbilirubinemia

• IRAS ID

  84237

• Contact name

  Marta Boffito

• Sponsor organisation

  St Stephen's Aids Trust

• Eudract number

  2011-001913-14

• ISRCTN Number

  not issued

• Research summary

  This study is being conducted because the most common side effect of the HIV drug atazanavir (taken with ritonavir) is raised levels of bilirubin. 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, however, some patients do not like this side effect and it is the most common 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 assess if using zinc supplements can achieve the same effect in patients with high bilirubin due to atazanavir use. Up to 16 HIV-1 infected adults who are currently receiving a combination of Truvada, atazanavir and ritonavir will participate in this trial. The trial participants will be randomly allocated to one of two groups: Arm A - will take zinc (as Solvazinc, 1 tablet dissolved in water) for 14 days from day 2 to day 15; or Arm B - will take zinc (as Solvazinc, 1 tablet dissolved in water) for 14 days from day 15 to day 29 Participants will continue to take their regular anti-retroviral medication after the study is over. Participants will be asked to visit the unit on up to 8 occasions, on 3 of these they will need to stay in the unit for the whole day (approximately 14 hours). This study is a randomised and open-label study.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1401

• Date of REC Opinion

  8 Nov 2011

• REC opinion

  Further Information Favourable Opinion