RESIST Trials

In combination therapy for HIV positive treatment-experienced patients
APTIVUS/ritonavir* in HIV-positive, clinically advanced, triple-class–experienced patients

RESIST Trials: (Randomized Evaluation of Strategic Intervention in multi-drug resiStant patients with Tipranavir) In the largest combined trial of treatment-experienced patients (n=1483), APTIVUS/r achieved twice the rate of treatment response and twice the virologic response vs CPI/r^† in a challenging population (P<0.0001). Treatment response was defined as having a confirmed ≥1 log₁₀ copies/mL drop in pVL at 48 weeks.

Patient inclusion criteria

• Received ≥3 months of NRTI, NNRTI, and PI therapy
• Received at least 2 PI-based antiretroviral (ARV) regimens for ≥3 consecutive months and a PI-based regimen at the time of study entry
• One or more primary PI-associated mutations
• HIV viral load (VL) ≥1000 copies/mL (≥3 log₁₀ copies/mL)
• 85% of patients were possibly resistant or resistant to the pre-selected CPI/r

Patient population

• A median of 12 ARVs were used before entry into the trial
• 70% had used ≥4 PIs before entry into the trial
• 38% of patients had baseline HIV RNA of ≥100,000 copies/mL
• 58% had experienced a prior AIDS-defining Class C event at baseline
• 13% had Hepatitis B and/or Hepatitis C
• 67% had ≥2 PI mutations at baseline

Comparator PIs assigned based on genotypic testing and medical history^‡

• 49% received lopinavir
• 26% received amprenavir
• 22% received saquinavir
• 3% received indinavir

Patient regimens

• Patients received either APTIVUS/r with an Optimized Background Regimen (OBR) or a CPI/r with an OBR
• 21% of patients used enfuvirtide (ENF)

*APTIVUS 500 mg co-administered with 200 mg of ritonavir. This is known as APTIVUS/ritonavir, or APTIVUS/r.
† Comparator ritonavir-boosted protease inhibitors.
‡ Genotypic and/or phenotypic resistance testing of baseline virus may aid in determining APTIVUS susceptibility before initiation of therapy.