PK of TFV,TFV-DP,FTC,FTC-TP & RPV in healthy volunteers study

• Research type

  Research Study

• Full title

  Pharmacokinetics of tenofovir and tenofovir-diphosphate, emtricitabine and emtricitabine-triphosphate, and rilpivirine once daily over 14 days following drug intake cessation in healthy volunteers

• IRAS ID

  114866

• Contact name

  Marta Boffito

• Sponsor organisation

  Chelsea and Westminster NHS Foundation Trust

• Eudract number

  2012-002781-13

• ISRCTN Number

  xx

• Research summary

  The purpose of the study is to look at the levels of three HIV medications: tenofovir, emtricitabine, and rilpivirine in blood after the drug intake has been stopped in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for 14 days. If the participant decides to take part, the duration of the study will be up to 23 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 16-22 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order. The participant and the study doctor will know which study medications the participants taking at all times during the study. The participant will need to stay at the study centre all day (12-14 hours) on one occasion during the study.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  13/LO/0047

• Date of REC Opinion

  4 Feb 2013

• REC opinion

  Favourable Opinion