The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre Toronto General Hospital Université de Montréal