Fig. 2

Screening, assessments and interventions schedule for iHIVARNA phase IIa. ¹ screening at most 8 weeks prior to enrollment at W0. Interval of 4 to 2 weeks is advised and optional consideration period of up to 2 weeks is offered. ² F full visit, L laboratory alone, P phone call. ³ full physical examination vs. vitals/lymph nodes alone. A full physical examination must be performed during follow-up when clinically indicated. ⁴ applicable to female subjects (reproductive age and not anatomically sterilized). Intranodal injection and treatment interruption is only allowed after a negative pregnancy test. ⁵ laboratory tests for safety includes hemoglobin, hematocrit, leucocytes, antibodies. Neutrophil count, thrombocytes, creatinine, aspartate aminotransferase (ASAT), alanine transaminase (ALAT), gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP), total bilirubin, amylase (or lipase), creatine kinase (CK, known as creatine phosphokinase), glucose, CD4+ and CD8+ cells and HIV viral load. ⁶ follow-up of vital signs (RR/pulse) at 5 min and 60 min after injection. ⁷ cART treatment interruption (ATI) starting from week 6 up to week 18. When there is an undetectable viral load at week 18, ATI is continued until week 30. Schedule according to template available from SPIRIT Statement,© 2013 Chan et al. [12]