The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers

Summary

Infection by both HIV and hepatitis C virus (HCV)is frequent due to similar transmission modes. Near 20% of people living with HIV are also infected by HCV. People living with HIV are treated by anti-HIV medications that may interact with numerous other medications, including new medications against HCV.

Boceprevir is one of these new HCV medications and it is now considered as part of the standard of care for people infected with HCV. Previous research has shown boceprevir may influence the capacity of the liver to breakdown (metabolize) certain medications and when these medications are used in combination with boceprevir, their blood concentrations may be increased or decreased which could increase the risk of side effects or decrease efficacy. Among the drugs having a potential for an interaction with boceprevir is maraviroc, an anti-HIV medication. If concentrations of maraviroc increase, people may experience more side effects. However, if concentrations of maraviroc decrease, people living with HIV may have a lower suppression of the virus. This could increase the risk for the HIV virus to develop resistance, that is that the treatment will no longer be effective. No studies have been conducted to investigate the effects of boceprevir on blood concentrations of maraviroc. This research project addresses this research question. This project, however, cannot be done with people living with HIV since resistance may develop in these people if the concentrations of maraviroc decrease. It is for this reason that the investigators wish to recruit healthy people not infected with HIV nor HCV.

Eleven healthy volunteers will be included. They will receive maraviroc 150 mg (1 tablet) every 12 hours from days 1 to 19 inclusively. On day 5, a total of ten blood samples will be drawn during the following 12 hours (at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours after maraviroc morning dose intake) to measure the blood concentrations of maraviroc. Boceprevir 800 mg (4 capsules) every 8 hours with food will be started on day 6 and continued until day 19 inclusively. On day 19, after the morning maraviroc and boceprevir dose, another ten blood samples will be drawn over a 12 hour period. A phone follow-up will be done on day 26. Thus, the total study duration for subjects is 26 days. The investigators will compare the blood concentrations of maraviroc when given alone to the blood concentrations of maraviroc when given with boceprevir.

Conditions

• Healthy

Interventions

DRUG

Maraviroc (5 days)

Subjects will receive maraviroc 150 mg tablets (1 tablet) every 12 hours from days 1 to 5 inclusively.

DRUG

Maraviroc and boceprevir (14 days)

From days 6 to 19, inclusively, boceprevir 800 mg (4 capsules of 200 mg) every 8 hours with food will be given with maraviroc 150 mg (1 tablet of 150 mg) every 12 hours.

Sponsors & Collaborators

• Université de Montréal

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• Toronto General Hospital

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• Cecile Tremblay, MD · Centre hospitalier de l'Université de Montréal (CHUM)

• Line Labbé, PhD · Faculté de pharmacie, Université de Montréal

• Nancy L Sheehan, B.Pharm, MSc · Faculté de pharmacie, Université de Montréal

• Alice Tseng, PharmD · Toronto General Hospital

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2013-04-30

Completion

2014-02-28

Countries

• Canada

Study Locations