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