Guidelines for Most Grade 3 Toxicities Sample Clauses

Guidelines for Most Grade 3 Toxicities. Participants who develop a Grade 3 adverse event or toxicity judged to be study drug-related should have one or more of their study ARVs switched or the entire regimen held. The participant should be re-evaluated weekly until the adverse event returns to Grade 2, at which time study treatment may be reintroduced at the discretion of the investigator or according to standard practice, depending upon the type of adverse event. Investigators are encouraged to discuss toxicity management with the A5208/OCTANE CMC, which should be notified of regimen changes or modifications and, as necessary, consulted for advice. If the relationship between study drug and the Grade 3 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 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.