PK of TMC278LA for use in pre-exposure prophylaxis

• Research type

  Research Study

• Full title

  A pharmacokinetic evaluation of the exposure and distribution of TMC278LA for use as pre-exposure prophylaxis, in plasma and genital tract /rectal compartments, following a single intramuscular dose at different doses in HIV-negative healthy volunteers.

• IRAS ID

  64816

• Contact name

  Marta Boffito

• Sponsor organisation

  St Stephen's Aids Trust

• Eudract number

  2010-023012-14

• ISRCTN Number

  Not Known

• Research summary

  TMC278 (also called rilpivirine) is a new drug being developed for the treatment of HIV. It is hoped that this drug may also be used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has been developed. Long acting means that the drug will be present in the blood for longer.The purpose of this study is to investigate the levels of the drug in the blood and genital fluids (vaginal and rectal) as well as the safety and how well it is tolerated by the body. The trial will not be investigating whether the drug prevents HIV and will recruit HIV negative volunteers whose lifestyles are low-risk for getting HIV. The study will last 84 days, plus a screening (which will take place up to six weeks prior to the first visit) and a follow up visit (which will take place up to four weeks after day 84). This study will recruit up to 66 volunteers (60 female and 6 male). Once enrolled, the study will involve 1 injection on the first day. There will be 10 other visits in the weeks following the injection, where participants will attend to measure drug levels (in blood and genital fluids) and on two occasions a small piece of tissue will be collected from the vagina or rectum. All participants receive a single dose, male participants will receive a single dose of 600mg, female participants will be randomised to receive a single dose of either 150mg, 300mg, 600mg or 1200mg.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/78

• Date of REC Opinion

  25 Nov 2010

• REC opinion

  Further Information Favourable Opinion