The raltegravir 60+ study

• Research type

  Research Study

• Full title

  An open label study to investigate the safety, pharmacokinetic profile and efficacy of raltegravir in HIV-infected patients at least 60 years of age. ‘The raltegravir 60+ study’

• IRAS ID

  67343

• Contact name

  Alan Winston

• Sponsor organisation

  Imperial College London

• Eudract number

  2010-022907-23

• ISRCTN Number

  N/A

• Research summary

  An open label study to investigate the safety, pharmacokinetic profile and efficacy of raltegravir in twenty HIV-infected patients at least 60 years of age. Subjects who are stable on antiretroviral therapy with an undetectable HIV viral load and have no evidence of previous HIV resistance will be switched at baseline to tenofovir/emtricitabine 245/200 mg (Truvada?½) daily plus raltegravir 400 mg twice daily. On day 28, subjects will undergo a 24 hour pharmacokinetic visit. During the study period, subjects will attend on days 14, 90 and 180 for follow up visits.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/124

• Date of REC Opinion

  17 Mar 2011

• REC opinion

  Further Information Favourable Opinion