Table 1. Criteria for diagnosing paradoxical and unmasking IRIS.

Unmasking IRIS

Clinical criteria     1. Temporal relationship: ART initiation precedes clinical deterioration     2. New onset of symptoms of an infectious or inflammatory condition after initiating ART     3. Consistent with the presence of pre-existing causative pathogen or antigen when starting ART     4. Either of the following:         a. Onset within 3 months after initiating ART         b. Atypical or exaggerated clinical, histological, or radiological findings in terms of severity, character of inflammatory response, rapidity of onset, or localization     5. Exclusion of other causes     6. Events not explained by:         a. Expected clinical course of another condition         b. Drug toxicity         c. Newly acquired infection, based on clinical history or other evidence         d. Failure of ART: presumptive, based on either nonadherence or resistance to ART, or confirmed, based on VL assay if available