Trial Design

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.

  1. Arm A: boosted protease inhibitor (bPI) + 2 nucleoside reverse transcriptase inhibitors
  2. (NRTIs) chosen by clinician according to local standard of care and availability
  3. Arm B: bPI + raltegravir
  4. 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:

  1. No new WHO Stage 4 events between randomisation and week 96 AND
  2. CD4 count > 250 cells/mm3 at week 96 AND
  3. 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.

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