A Prospective and Retrospective, Observational Multicentre Ibalizumab Study of Efficacy (PROMISE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  IBALIZUMAB
• Medical condition to be studied:
  HIV infection

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  951

Study design details

• Main study objective:
  Primary Objective: To evaluate the long-term efficacy and durability of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment vs. matched patients not receiving ibalizumab.
• Outcomes:
  Virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment vs. matched patients not receiving ibalizumab. Virologic, immunologic and clinical outcomes of patients before and after they receive ibalizumab treatment.
• Data analysis plan:
  The Full Analysis set (FAS) will include all enrolled patients in cohort 2 and their match-control patients from cohort 1. The Per Protocol Analysis set (PP) will include the subgroup of patients from cohort 2 who were prescribed ibalizumab as per the approved indication and their match-control patients from cohort 1. The All Enrolled set (AllE) will include all patients from cohort 1 (matched and unmatched patients) and cohort 2. The Safety Analysis set (SAF) will include all enrolled patients in cohort 2 who received at least one dose of ibalizumab.