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Published in: Journal of the International AIDS Society 4/2010

Open Access 01-12-2010 | Poster presentation

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

Authors: R Cuffe, M Ait-Khaled, S Hughes, S Min, G Nichols, D Thomas, M Underwood, JM Yeo

Published in: Journal of the International AIDS Society | Special Issue 4/2010

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Excerpt

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. …
Metadata
Title
Novel monitoring technique to minimise the risk for patients participating in pilot studies of investigational compounds
Authors
R Cuffe
M Ait-Khaled
S Hughes
S Min
G Nichols
D Thomas
M Underwood
JM Yeo
Publication date
01-12-2010
Publisher
BioMed Central
DOI
https://doi.org/10.1186/1758-2652-13-S4-P228

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