This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects currently attending for HIV care at St. Mary's Hospital, London will be eligible.
The study will describe the steady state pharmacokinetic parameters and short term safety of maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects. Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving antiretroviral therapy comprising: * tenofovir/emtricitabine 245/200 mg daily plus * darunavir/ritonavir 800/100 mg daily On day 1, subjects will modify their current antiretroviral therapy to the following: * tenofovir/emtricitabine 245/200 mg daily plus * darunavir/ritonavir 800/100 mg daily plus * maraviroc 150 mg daily On day 10 subjects will undergo an intensive pharmacokinetic visit. On day 11, subjects will modify their current antiretroviral therapy to the following: * darunavir/ritonavir 800/100 mg daily plus * maraviroc 150 mg daily (i.e. tenofovir/emtricitabine will be discontinued) 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
13
Imperial College Healthcare NHS Trust
London, United Kingdom
The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day
On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured .
Time frame: 10 day, 20 days
Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests
Haematology and biochemistry laboratory tests such as full blood count, elelectrolytes and lipids will be measured to assess for changes.
Time frame: 35 days
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