ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered
      at 50 mg and 150 mg o.d. versus placebo in HIV infected patients who are treated with
      darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI).
    

Detailed description: 
      This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered
      at 50 mg o.d. and 150 mg versus placebo in HIV infected patients who are treated with
      darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI). Eligible patients
      should be treated with darunavir + ritonavir or darunavir + cobicistat as monotherapy for at
      least 8 weeks prior to baseline. Patients should be fully suppressed (< 50 copies/mL) at
      least during the last 6 months prior to enrolment.

      Upon screening visit, eligible patients will continue DRV/RTV or DRV/COBI single regimen
      given respectively at 800 mg of darunavir with 100 mg of ritonavir or 150 mg of cobicistat
      once a day with food in the morning.

      At Day 0, study drug (ABX464 or its matching placebo) will be added on top of this background
      therapy for the next 28 days. ABX464 or its matching placebo will be given once a day at 50
      mg or 150 mg.

      At day 29, DRV/RTV or DRV/COBI and ABX464 or its matching placebo (i.e. all treatments) will
      be stopped. The viral load will be monitored twice a week during the first three weeks and
      weekly during the next weeks. In case of Viral Rebound (VR; defined below), ART will be
      resumed.

      A 3:1 randomization ratio will be applied meaning that, per treatment block, 3 patients will
      receive ABX464 on top of DRV/RTV or DRV/COBI and 1 patient will receive placebo on top of
      DRV/RTV or DRV/COBI.

      Dose limiting toxicity (DLT) is defined as a grade 3 or higher adverse event as defined by
      the "Division of AIDS table for grading the severity of adult and pediatric adverse events"
      (including signs/symptoms, lab toxicities and/or clinical events) considered by the Data
      Safety Monitoring Board as probably or definitely related to study treatment.

      If more than 2 DLTs occur during the treatment period of the first four treated patients,
      then the enrolment of additional patients will be stopped. In addition, in case of a life
      threatening (grade 4) adverse reaction enrolment and treatment of ongoing patients will be
      immediately discontinued. In both cases, enrolment will only be resumed upon the decision of
      the sponsor if the Data Safety Monitoring Board can conclude that the causality of the event
      was unrelated or unlikely related to study treatment.

      Thorough pharmacokinetics analysis will be performed to characterize potential drug-drug
      interactions between ABX464 and DRV/RTV-COBI.
    

Intervention name(s): ABX464; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg or 150mg once daily for 28 days; ABX464 matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment