The Darunavir/r Raltegravir PK Study Protocol Version 1
A prospective pharmacokinetic study to investigate the steady state pharmacokinetic profile of darunavir/ritonavir when dosed once daily with tenofovir/emtricitabine, tenofovir/emtricitabine/raltegravir, and raltegravir alone in HIV-1 infected subjects.
Imperial College London
The purpose of the study is to look at the levels of the study drugs darunavir and ritonavir in the blood when these drugs are given with and without two other HIV antiretroviral drugs -raltegravir and Truvada. Furthermore the study will evaluate the good and bad effects of the study drugs and how well people tolerate darunavir and ritonavir when given in combination with raltegravir and Truvada â„¢. The duration of the study will be up to 45 days plus a screening visit which will take place 1 - 3weeks prior to the start of the study. The study is looking at how much of the drug stays in your blood after you have taken it. Blood will be taken at set times through the day to measure the levels. Participants will attend the clinic early in the morning when a small plastic needle will be inserted into a vein in their arm to obtain the blood samples through during the day. They will then be given breakfast and then the study medication. Blood will then be collected 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the dose. The plastic needle will be removed after the last blood is taken. Participants will need to remain in the clinic through this time and to also attend the following morning for a final 24 hour post dose blood test. During the study participants will be asked to attend 3 of these long days.
London - Central Research Ethics Committee
Date of REC Opinion
3 Oct 2008
Further Information Favourable Opinion