The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers
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.
Drug: Maraviroc (5 days)
Drug: Maraviroc and boceprevir (14 days)
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers|
- Change in maraviroc AUC [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
- Change in maraviroc Tmax [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Up to day 26 ] [ Designated as safety issue: Yes ]Adverse events will be graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2004).
- Change in maraviroc Cmax [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
- Change in maraviroc Cmin [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
- Change in maraviroc Cl/F [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
- Change in maraviroc Vd [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
- Change in maraviroc T1/2 [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: Maraviroc Boceprevir||
Drug: Maraviroc (5 days)
Subjects will receive maraviroc 150 mg tablets (1 tablet) every 12 hours from days 1 to 5 inclusively.
Other Name: Celsentri (DIN #: 02299844) CAS# 376348-65-1Drug: 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.
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|Contact: Nancy L Sheehan, B.Pharm, MSc||514-343-6111 ext email@example.com|
|Contact: Dominic Martel, B.Pharm, MSc||514-406-5117||Dominic.Martel@uhn.ca|
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montréal, Quebec, Canada, H2W 1T8|
|Contact: Cécile Tremblay, MD 514-890-8148 firstname.lastname@example.org|
|Principal Investigator: Cecile Tremblay, MD|
|Principal Investigator:||Cecile Tremblay, MD||Centre Hospitalier de l'Université de Montréal|
|Principal Investigator:||Line Labbé, PhD||Faculté de pharmacie, Université de Montréal|
|Principal Investigator:||Nancy L Sheehan, B.Pharm, MSc||Faculté de pharmacie, Université de Montréal|
|Study Director:||Alice Tseng, PharmD||Toronto General Hospital|