Atripla Tail Study

• Research type

  Research Study

• Full title

  Pharmacokinetics of tenofovir and tenofovir-diphosphate, emtricitabine and emtricitabine-triphosphate, and efavirenz once daily over 10 days following drug intake cessation in healthy volunteers

• IRAS ID

  43180

• Contact name

  Marta Boffito

• Sponsor organisation

  St Stephen's AIDS Trust

• Eudract number

  2009-018055-16

• ISRCTN Number

  Not Sent

• 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. The study is being conducted as we have found that successful long term treatment of patients is limited by many factors including missed or delayed doses. The aim of the study is to look at the blood levels of Atripla© after 14 days of drug intake and over 14 days after drug intake has been stopped, this is to help to understand what happens to blood levels of the study drugs when patients using these drugs forget or delay drug intake. Participants will receive a tablet containing a combination of these three medications (tenofovir, emtricitabine, and efavirenz) known as Atripla©. On days 1-14, participants will take 1 tablet (containing tenofovir 300mg, emtricitabine 200mg, and efavirenz 600mg) once daily in the evening on an empty stomach. The duration of the study will be up to 24 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 7-13 days after the last dose of study medication. Participants will be asked to visit the clinic on up to 17 occasions, of which one visit involves admission to the unit for an overnight stay through to the following evening (Days 14 and 15). 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 - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/11

• Date of REC Opinion

  27 Apr 2010

• REC opinion

  Further Information Favourable Opinion