Darunavir/ritonavir and raltegravir pharmacokinetic study

• Research type

  Research Study

• Full title

  Plasma and intracellular pharmacokinetics of once daily darunavir/ritonavir and twice daily raltegravir in HIV-infected subjects.

• IRAS ID

  14251

• Sponsor organisation

  St Stephen's Aids Trust

• Eudract number

  2008-008321-30

• ISRCTN Number

  Not submitted

• Research summary

  The Human Immunodeficiency Virus (HIV) attacks the body's immune system, which provides a natural defence system against disease and infection. The HIV virus can be spread through the exchange of bodilfluds, such as blood, semen, and vaginafluds.The successful treatment of HIV requires the use of a combination of different drugs. Before using different combinations of drugs, it is important to see if the drugs will affect the activity of each other. We aim in this study to look at the blood levels of darunavir/ritonavir (a protease inhibitor treatment for HIV) and raltegravir (an integrase inhibitor of HIV) both when they are each given on their own, and when they are given at the same time. Up to 34 HIV-1 infected adults who are currently on a stable HIV medication regime will participate in all 3 phases of this trial for 50 days (excluding screening and follow up). Phase 1 of the trial, day 1-21; all participants will take their usual drugs (the N(t)RTI nucleoside/nucleotide reverse transcriptase inhibitor) plus raltegravir 400mg twice daily. Phase 2 of the trial, day 22-35; participants will be randomly (like flipping a coin) allocated to either group 1 or group 2 at a 1:1 ratio:Group 1: Darunavir/ritonavir 800/100mg once daily plus raltegravir 400 mg twice dailyGroup 2: Darunavir/ritonavir 800/100mg once daily plus raltegravir 800 mg once dailyPhase 2 of the trial lasts for 14 days.Phase 3 of the trial, days 36-50; all participants will take their usual NRTI and darunavir/ritonavir 800/100 mg once daily for 14 days.This study is open label which means that both the study team and the participant will know which treatment group they have been assigned to.There is also an optional pharmacogenetic blood sample as part of this study. This is entirely optional and if subjects wish to participate they will be asked to sign a separate consent form. Pharmacogenetic research uses DNA samples (of the genes) from healthy and ill individuals to do the following:- study the causes of human diseases - help understand how different individuals respond to drugs - obtain information to help develop new methods to diagnose and treat diseases This is a single centre study with a treatment period of 50 days plus a screening visit which will take place up to 4 weeks prior to the start of the study, and a follow up visit which takes place 1-2 weeks after the last dose of study medication. Participants will be asked to visit the unit on up to 12 occasions, on 3 of these they will need to stay at the unit for the whole day (approximately 12 hours).

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/9

• Date of REC Opinion

  2 Apr 2009

• REC opinion

  Further Information Favourable Opinion