INROADS, Abbreviated Title: Intelence aNd PRezista Once A Day Study

This study is a Phase II single arm, open-label, multicenter, (all people involved know the
identity of the intervention) study of 50 HIV-1 infected adult patients, all of whom will
receive ETR 400mg and darunavir (DRV)/r 800/100mg each given orally once daily. This trial
is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the
percentage of patients with HIV ribonucleic acid (RNA) <50 copies/mL at 48 weeks, in early
treatment-experienced HIV-infected patients. In addition to general safety parameter
measurements, this trial will also assess changes in metabolic, inflammatory, immune
restoration, and bone markers. Screening will occur over a 6-week period. The trial schedule
includes a Baseline Visit (Day 1), Open-label Treatment Phase (Weeks 4, 8, 12, 16, 20, 24,
30, 36, 42, 48/ Early Withdrawal) and a Post-treatment Phase (4 Week Follow-Up) visit. In
addition, all patients will have two pharmacokinetic (PK) samples drawn at Weeks 4 and 24, A
single PK sample will be drawn at Weeks 12, 36, and 48 (or early withdrawal visit). There
will also be a substudy conducting 24 hour intensive PK at week 4 for a subset of patients.
For patients who consent, genotyping for CYP2C9 and CYP2C19 will be performed at Baseline. A
Modified Medication Adherence Self-Report Inventory (M-MASRI) questionnaire will be
collected, which is a patient-reported survey to assess adherence to medication taking. The
primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end
of study endpoint will be met by either completing the Week 48 visit, or by early
termination from the study for any reason. ETR 400mg once daily for 48 weeks and DRV 800mg
once daily for 48 weeks.