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Boceprevir and Ucalm (St John&Apos;s Wort)

NCT01663922 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-09-29

Study results available
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Summary

The purpose of the study is to look at whether taking a new medication for hepatitis C (boceprevir) together with a herbal remedy commonly used for the treatment of depression (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir is taken on its own.

Treatment of hepatitis C genotype-1, has recently been significantly improved with the addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this class of antiviral drugs and it is administered in combinations with other drugs to treat hepatitis C. One of the common side effects of treatment for hepatitis C is low mood (depression) for which treated patients may self-medicate with preparations containing St. Johns Wort (SJW).

SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may result in a change in how both of these drugs usually work. It is therefore important to find out if the levels of boceprevir in the blood are significantly affected by taking SJW.

The study aims to help us understand whether it will be safe to take SJW whilst being simultaneously treated for hepatitis C with boceprevir.

Conditions

  • Hepatitis C

Interventions

DRUG

Boceprevir

Boceprevir as Victrelis(r) 200mg capsules

DRUG

St John's Wort

Each Ucalm(r) tablet contains 300mg of St Johns Wort extract

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • University of Turin, Italy

    collaborator OTHER

  • St Stephens Aids Trust

    lead OTHER

Principal Investigators

  • Marta Boffito · HIV Consultant

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-12-31
Completion
2012-12-31

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 NCT01663922 on ClinicalTrials.gov