This is a three arm parallel group, open-label, multi-centre, randomised controlled trial

The trial aims to determine whether, in patients failing a first-line NRTI and NNRTI-containing regimen:

1. the use of bPI plus raltegravir (an integrase inhibitor) is superior to standard of care (bPI plus 2 new NRTIs) in achieving good HIV disease control at 96 weeks after randomisation.
2. the use of bPI monotherapy is non-inferior to standard of care in achieving good HIV disease control at 96 weeks after randomisation.

1200 patients will be included in the study

Patients will be randomised in a ratio of 1:1:1 to one of the following three treatment arms.

•  Arm A: bPI + 2 NRTIs* chosen by clinician according to local standard of care and availability
• Arm B: bPI + raltegravir 400 mg twice daily
• Arm C:bPI alone (after an initial 12-week induction phase with raltegravir)

The bPI will be standardised to Aluvia (lopinavir/ritonavir 400 mg/100 mg b.d.).

The trial will have a 12 months recruitment period and each patient will be followed for 144 weeks

Good HIV disease control at 96 weeks defined as a composite endpoint consisting of all of:

• No new WHO Stage 4 events between randomisation and week 96 (other than oesophageal candidiasis or mucosal HSV which are recognised to be less severe conditions, see p55) AND
• CD4 count > 250 cells/mm3 at week 96 AND
• VL < 10,000 copies/ml or > 10,000 copies/ml with no PI resistance mutations at week 96