Atazanavir/Ritonavir and Zinc Pharmacokinetic Study

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Stephens Aids Trust
• Treatments: Atazanavir Sulfate; Ritonavir; Zinc; Zinc Sulfate

Criteria

Inclusion Criteria:

1. 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

2. Male or non-pregnant, non-lactating females.

3. Aged between 18 to 65 years, inclusive.

4. Documented HIV-1 infection

5. Plasma HIV RNA less than 40 copies/mL (note retesting of screening viral load is allowed).

6. CD4 count > 100 at screening (note retesting of screening CD4 count is allowed).

7. Receiving an antiretroviral regimen of Truvada and atazanavir/ritonavir for more than 3 months.

8. Serum total bilirubin concentration greater than 25 micromol/L

9. Agrees not to change regimen, outside the study recommendations, from baseline until end of the treatment period unless this is medically indicated as decided by their treating physician.

Exclusion Criteria:

1. Any serious or active medical or psychiatric illness, which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic disorders or malignancy.

2. Body mass index (BMI) >35 kg/m2

3. Presence of any current active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions:

• Stable cutaneous Kaposi's Sarcoma

4. Clinically relevant alcohol or drug use (positive urine drug screen, with the exception of cannabinoids) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events.

5. The use of zinc supplements for 1 month before screening and disallowed concomitant therapy (See Concomitant Medication and treatment, section 5.2) or medication that may interfere with the study results (as determined by the principal investigator).

6. Females of childbearing potential who are not using effective non-hormonal birth control methods or not willing to continue using these birth control methods for at least 14 days after the end of the treatment period.

7. Previous allergy to any of the constituents of the zinc sulphate tablets administered in this trial.

8. Subjects with laboratory evidence of significantly decreased hepatic or renal function (as determined by the principal investigator).

9. Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug