Guidelines for Most Grade 4 Toxicities Sample Clauses

Guidelines for Most Grade 4 Toxicities. Participants who develop a symptomatic Grade 4 adverse event or toxicity will have all study treatment withheld until resolution of the adverse event to a Grade 2. Alternative study-provided or non-study provided medications should replace the study treatment thought to be most likely related to the adverse event, once ART is restarted. If the relationship between study drug and the symptomatic Grade 4 event is uncertain, the study drug of concern may be resumed at the discretion of the site investigator, only after discussion with the A5208/OCTANE CMC, and with the exceptions noted below in section 7.5. Participants with Grade 4 asymptomatic laboratory abnormalities may continue study treatment after discussion with the A5208/OCTANE CMC only if the site investigator has compelling evidence that the toxicity is NOT related to the study treatment and with the exceptions noted below in section 7.5. Participants experiencing adverse events requiring permanent discontinuation of NVP or LPV/RTV study treatment should be followed weekly until resolution of the adverse event to Grade ≤1 or until stabilized and no longer in need of such frequent monitoring, as determined by the site investigator.
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