The maraviroc darunavir/r once daily PK study.
Research type
Research Study
Full title
A phase 1 pharmacokinetic study to assess the steady state pharmacokinetic profile and short term safety of maraviroc dosed with darunavir/ritonavir all once daily, with and without nucleoside analogues, in HIV-1 infected subjects.‘The maraviroc darunavir/r once daily PK study’
IRAS ID
63409
Contact name
Alan Winston
Sponsor organisation
Imperial College London
Eudract number
2009-014924-42
ISRCTN Number
ISRCTN
Research summary
Fifteen HIV-1 infected eligible subjects who are currently receiving antiretroviral therapy comprising: tenofovir/emtricitabine 245/200mg (as fixed dose tablet Truvada) daily plus darunavir/ritonavir 800/100 mg daily will be enrolled. Phase I: Day 1, subjects will modify their current antiretroviral therapy to: tenofovir/emtricitabine 245/200 mg daily plus darunavir/ritonavir 800/100 mg daily plus maraviroc 150 mg daily. Phase II: Day 10 subjects will undergo an intensive pharmacokinetic visit. Day 11, subjects will modify their current antiretroviral therapy to the following: darunavir/ritonavir 800/100 mg daily plus maraviroc 150 mg daily On day 20 subjects will undergo an intensive pharmacokinetic visit. Following completion of this study phase, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.
REC name
London - Central Research Ethics Committee
REC reference
10/H0718/78
Date of REC Opinion
4 Nov 2010
REC opinion
Favourable Opinion