The Raltegravir and Ribavirin PK Study

• Research type

  Research Study

• Full title

  A prospective, open-label, three phase pharmacokinetic study, to assess the pharmacokinetic profile and safety of raltegravir 400 mg twice daily and ribavirin 800 mg once daily, when dosed separately and together in healthy volunteers.

• IRAS ID

  18343

• Contact name

  Alan Winston

• Sponsor organisation

  Imperial College, London

• Eudract number

  2009-010005-36

• ISRCTN Number

  ISRCTN

• Clinicaltrials.gov Identifier

  NCT

• Research summary

  The aim of this study is to assess the safety and pharmacokinetic profile of raltegravir 400 mg twice daily when dosed with and without ribavirin 800 mg daily, in healthy male and female volunteers.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0709/38

• Date of REC Opinion

  13 Jul 2009

• REC opinion

  Further Information Favourable Opinion