PrEP TMC278LA - SSAT037

• Research type

  Research Study

• Full title

  PrEP TMC278LA: safety, tolerability and pharmacokinetics of TMC278LA in HIV negative volunteers - SSAT037

• IRAS ID

  41273

• Contact name

  Marta Boffito

• Sponsor organisation

  St Stephens Aids Trust

• Eudract number

  2009-017631-17

• ISRCTN Number

  n/a

• Research summary

  TMC 278 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 safety of the drug and how well it is tolerated by the body. The trial will look at the levels of the study drug blood over the duration of the study. The people taking part will be healthy volunteers. The main part of the trial will be over 22 weeks, plus a screening visit which will take place up to six weeks prior to the start of the study, and a follow up visit which takes place about two months after the last study visit. This study is not randomised which means that all participants will receive the study medication. Participants will receive two injections a fortnight apart and then four more injections one month apart. Each injection volume will be the same dose and in the buttocks, alternating between left and right each time. In total participants will be asked to visit the clinic on up to 18 occasions, of which, six involve visiting the unit twice during the day to give blood. A small group of 20 males and females will also be asked if they will also participate in testing of drug levels respectively in semen or vaginaflud.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/8

• Date of REC Opinion

  15 Feb 2010

• REC opinion

  Further Information Favourable Opinion