Novel monitoring technique to minimise the risk for patients participating in pilot studies of investigational compounds

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. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P228 Cite this article as: Cuffe et al.: Novel monitoring technique to minimise the risk for patients participating in pilot studies of investigational compounds. Journal of the International AIDS Society 2010 13(Suppl 4): P228. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113014/