HIV Clinical Trial
Official 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
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.
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