Pharmacokinetics of switching from efavirenz to maraviroc

• Research type

  Research Study

• Full title

  A pilot evaluation of the pharmacokinetics, efficacy and safety of switching from efavirenz to maraviroc administered at 600mg then 300mg twice-daily in patients suppressed on an efavirenz-containing regimen as initial therapy

• IRAS ID

  30454

• Contact name

  Laura Waters

• Sponsor organisation

  St Stephen's Aids Trust

• Eudract number

  2009-014694-40

• ISRCTN Number

  Not Known

• 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. Before using different combinations, it is important to see if the drugs will affect the activity of one another. Maraviroc and efavirenz are drugs used for the treatment of HIV. This study aims to understand whether it is safe to change directly from efavirenz to maraviroc. Up to 15 HIV-1 infected adults who are currently receiving a combination based on efavirenz will participate in this trial. Participants will continue to take 2 of their usual drugs (NRTI or Ó?backbone drugs?) throughout the study. The first 14 days of the trial participants will take their usual NRTI but with maraviroc 600mg (2 pills) twice daily instead of efavirenz 600mg once daily. After the 14 days participants will take their NRTI but switch to maraviroc 300mg (1 pill) twice daily. After 24 weeks, the study will be over and participants will switch back to their old combination. Participants will be asked to visit the unit on up to 13 occasions, on 3 of these they will need to stay in the unit for the whole day (approximately 14 hours). 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 study.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/74

• Date of REC Opinion

  9 Nov 2009

• REC opinion

  Further Information Favourable Opinion