Maraviroc in HIV post exposure prophylaxis (MiPEP) Trial Version 1.0

• Research type

  Research Study

• Full title

  Randomised controlled trial of the tolerability and completion of maraviroc compared to Kaletra© in combination with Truvada© for HIV post-exposure prophylaxis

• IRAS ID

  83357

• Contact name

  Paul Benn

• Sponsor organisation

  Camden Provider Services

• Eudract number

  2011-003447-21

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Current national guidelines recommend HIV post exposure prophylaxis (PEP) in specific circumstances, however treatment completion rates are poor. This is mainly attributed to limited tolerability with the drugs used and therefore, identifying combinations likely to be better tolerated would be extremely useful. This is a parallel group, open-label, multi-centre, randomised controlled trial. 280 patients will be included who are adults in whom PEP is considered appropriate according to current guidelines following occupational or non-occupational exposure. Patients will be randomised to receive coformulated tenofovir disoproxil fumarate/emtricitabine (Truvada©) with either maraviroc (experimental arm) or lopinavir/ritonavir (Kaletra©) (control arm) for 28 days. The purpose of this study is to find out whether a PEP combination containing the antiretroviral maraviroc is superior to the standard PEP treatment regimen, in terms of the proportion of patients who complete a full course, and to compare clinical events, safety and toxicity between the two groups.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/1333

• Date of REC Opinion

  15 Dec 2011

• REC opinion

  Further Information Favourable Opinion