ATV/r and DRV/r PK Tail Study

• Research type

  Research Study

• Full title

  Pharmacokinetics of darunavir/ritonavir once daily and atazanavir/ritonavir once daily over 72 hours following drug intake cessation in healthy volunteers

• IRAS ID

  38903

• Contact name

  Marta Boffito

• Sponsor organisation

  St Stephen's AIDS Trust

• Eudract number

  2009-017170-21

• ISRCTN Number

  isrctn

• 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. There is no cure, or vaccine, for HIV infection. The successful treatment of HIV usually involves using a combination of different drugs. However, the long term use of and success of these drugs is limited by many factors including missing doses and side effects. Missing doses may lead to virological failure (an increase in viral load following suppression from treatment) and drug resistance which can limit future treatment options. The aim of the study is to look at the levels of three HIV medications darunavir, ritonavir and atazanavir in blood after the drug intake has been stopped in order to understand how long these drugs persist in blood for. The study will specifically look at these three drugs blood levels after taking them for 10 days everyday. This is to gain information to understand what happens to blood levels of the study drugs when patients using these drugs forget or delay drug intake. Participants will receive two different treatments in this study, each of these for 10 days and each separated by a wash out period of one week. Treatment one (days 1-10): Darunavir/ritonavir 800/100mg (two Prezista 400mg tablets and one Norvir 100mg capsule once daily in the morning on Days 1-10). Treatment two (days 18-27): Atazanavir/ritonavir 300/100mg (one Reyataz 300mg capsule and one Norvir 100mg capsule once daily in the morning on Days 18-27) Participants will be asked to visit the unit on up to 12 occasions, on 2 of these they will need to be admitted to the unit for overnight stay for one night. There is also an optional pharmacogenetic blood sample as part of this study. 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 an open-label, single centre, healthy volunteer study.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0709/3

• Date of REC Opinion

  23 Feb 2010

• REC opinion

  Further Information Favourable Opinion