1. 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)