Novel monitoring technique to minimise the risk for patients participating in pilot studies of investigational compounds
نویسندگان
چکیده
Background S/GSK1349572 is a new integrase inhibitor (INI) with in-vitro activity against INI-resistant HIV. Before dosing a large number of subjects in pivotal clinical trials, in-vitro findings were validated in a pilot clinical study (ING112961). At the outset of the study, the degree of susceptibility at which the drug no longer provides benefit was unknown. Planned enrollment for this study was 30 raltegravir (RAL)-resistant patients, incorporating a broad range of in-vitro susceptibility to S/GSK1349572. The clinical team developed novel stopping guidelines to minimise risk to study participants.
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