Assessed for eligibility (n = 38)

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Presentation transcript:

Assessed for eligibility (n = 38) OPAL HIV-1001 Flow diagram Enrollment Assessed for eligibility (n = 38) Excluded (n= 15) Early study closure (n=4) Prior experimental HIV immunotherapy (n = 2) Non-reactive to immunogenicity inclusion criteria (n = 2) Excluded antiretroviral therapy (n = 2) Withdrew before randomisation (n = 5) Allocation Randomised (n= 23) Allocated to Placebo (n= 9) Received allocated intervention (n= 8) Did not receive allocated intervention (n= 1) equipment failure Allocated OPAL12 mg (n= 6) Received allocated intervention (n= 6) Allocated OPAL 24 mg (n= 6) Received allocated intervention (n= 6) Allocated OPAL 48 mg (n= 2) Received allocated intervention (n= 2) Follow-Up Discontinued intervention (n=2) Early study termination (n=2) Discontinued intervention (n= 1) Treatment-emergent unrelated adverse event; continued follow-up without receiving further doses after 2nd administration Discontinued intervention (n= 2) Serious Adverse Event (n= 1) Early study termination (n= 1) Analysis Analysed (n= 8) Analysed (n= 6) Analysed (n= 6) Analysed (n= 2)