List of grade 2 or worse adverse events through end of study.
Gastrointestinal dysfunction, IRIS, Nausea, Vomiting,, Diarrhea/loose stools, Constipation
ADVERSE EVENT, IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME
Any (sign/symptom or lab) includes more levels than listed hereAny gastrointestinal includes: Appetite loss/decreased/anorexia, Constipation, Diarrhea/loose stools, Nausea, Vomiting, Gastrointestinal dysfunction.All p-values are calculated using the Kruskal-Wallis test for differences across the four treatment arms.The median (IQR) duration of hospitalisation was 18 (13, 28) days and was similar across cohorts. There was no significant difference in the subsequent hospitalisation by cohorts: 11(22%), 7 (15%) and 11(23%), 1600mg, 2000mg FCZ and AMB. Two participants developed immune reconstitution inflammatory syndrome (IRIS). One was in the 1200mg FCZ cohort, who commenced antiretroviral treatment on day 63 and manifested IRIS on day 99. The other was in the AMB cohort and commenced antiretroviral treatment on day 26 and manifested IRIS on day 38.QT prolongation is a specific adverse event of interest because of the high doses of FCZ and the blackbox warning for QTc with high dose FCZ and was specifically monitored with periodic ECGs. “