1. Trial Design
This is a three arm parallel group, open-label, multi-centre, randomised controlled trial.
2. Trial Patients
1200 HIV-infected adults who have taken a first-line NNRTI-based regimen for at least 2 years, and developed treatment failure defined by modified WHO 2006 criteria will be included in EARNEST
3. Trial Interventions
Patients will be randomised in a ratio of 1:1:1 to one of the following three treatment arms.
- Arm A: boosted protease inhibitor (bPI) + 2 nucleoside reverse transcriptase inhibitors
- (NRTIs) chosen by clinician according to local standard of care and availability
- Arm B: bPI + raltegravir
- Arm C: bPI alone (after an initial 12-week induction phase with raltegravir)
The bPI will be standardised to Aluvia (lopinavir/ritonavir 400mg/100mg b.d.).
4. Trial Duration
The trial will have a 1-year recruitment period and each patient will be followed for 144 weeks.
5. Outcome measures
Analyses will compare Arm A with Arm B and with Arm C by intention to treat (ITT). The primary outcome measure will be Good HIV disease control defined as a composite endpoint consisting of all of:
- No new WHO Stage 4 events between randomisation and week 96 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
Various secondary endpoints are also being assessed in this study.
