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Atazanavir/Ritonavir and Zinc Pharmacokinetic Study

NCT01475227 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-03-22

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

DRUG

1 Solvazinc tablet, day 2 to day 15

Zinc sulphate 125mg, day 2 to day 15

DRUG

1 Solvazinc tablet, day 15 to day 28

Zinc sulphate 125mg, day 15 to day 28

Sponsors & Collaborators

  • St Stephens Aids Trust

    lead OTHER

Principal Investigators

  • Marta Boffito, Dr · St Stephen's AIDS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475227 on ClinicalTrials.gov