A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study).

A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study).

The CHARM-01 study characterized the safety, acceptability, pharmacokinetics (PK), and pharmacodynamics (PD) of three tenofovir (TFV) gels for rectal application. The vaginal formulation (VF) gel was previously used in the CAPRISA 004 and VOICE vaginal microbicide Phase 2B trials and the RMP-02/MTN-...

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Bibliographic Details
Main Authors: Ian Mcgowan, Ross D Cranston, Kathryn Duffill, Aaron Siegel, Jarret C Engstrom, Alexyi Nikiforov, Cindy Jacobson, Khaja K Rehman, Julie Elliott, Elena Khanukhova, Kaleab Abebe, Christine Mauck, Hans M L Spiegel, Charlene S Dezzutti, Lisa C Rohan, Mark A Marzinke, Hiwot Hiruy, Craig W Hendrix, Nicola Richardson-Harman, Peter A Anton
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2015-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC4420274?pdf=render

Internet

http://europepmc.org/articles/PMC4420274?pdf=render

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