Capsid Study

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long Acting Capsid Inhibitor GS-6207 in Combination with an Optimized Background Regimen in Heavily Treatment Experienced People Living with HIV-1 Infection with Multidrug Resistance

Heavily treatment experienced adults and adolescent PLWH with resistance to ≥ 2 antiretroviral medications from each of ≥ 3 of the 4 main classes of antiretroviral medication and plasma HIV-1 RNA ³ 400 copies/mL at Screening while taking a failing regimen.

 

Key Inclusion Criteria:

  • Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)
  • Currently receiving a stable failing antiretroviral (ARV) regimen for > 8 weeks
  • Have HIV-1 RNA ≥ 400 copies/mL at screening
  • Have multidrug resistance
  • Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen
  • Able and willing to receive an optimized background regimen together with GS-6207
  • No Hepatitis C virus (HCV) ongoing infection

 

Key Exclusion Criteria

  • Recent (< 5 years) or ongoing malignancy  other than Kaposi’s Sarcoma, basal cell carcinoma or non-invasive cutaneous squamous carcinoma.
  • Active, serious infection requiring parenteral antibiotic or antifungal within 30 days of screening
  • Treatment with immunosuppressant or chemotherapeutic agents within three months of screening
  • GFR < 60 mL/min by Cockcroft-Gault,
  • ALT > 5 x ULN,
  • Direct bilirubin > 1.5 x ULN
  • Platelets < 50,000/mL
  • Hemoglobin < 8 g/dL