Severity criteria
Hyponatremia, bleeding, Thrombocytopenia, fever, Fever, infection, Anemia, lung opacities, Hypoalbuminemia
HYPONATREMIA, PLEURAL EFFUSION, BLEEDING, THROMBOCYTOPENIA, INFECTION, ANEMIA, LYMPHEDEMA, HYPOALBUMINEMIA
For this trial, non-severe-IRIS-KS was considered in patients with an increase in the number of KS lesions plus a decrease of ≥one log10 of HIV-1 RNA VL or an increase of ≥50 cells/mmClinical criteria: 1) Fever (without identified concomitant infection), 2) increase in the size or number of KS lesions, 3) exacerbation of lymphedema, 4) appearance or increase of otherwise unexplained lung opacities on the chest images with a negative Gallium-Scan and 4) appearance or increase of volume of pleural effusion.Laboratory criteria: 1) Thrombocytopenia <100,000 platelets/ml; 2) Anemia (decrease of at least 1 g/dl from previous measure with no obvious bleeding), 3) Hyponatremia <135 mEq/L and 4) Hypoalbuminemia <3.5 g/dL. Patients with severe IRIS KS can respond to bleomycin/vincristine therapy. We defined the resolution of a Severe-IRIS-KS: when platelets normalized, Hb increased (not due to a blood transfusion), albumin and sodium improved, and fever resolved.