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

OBJECTIVES: 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...

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Detalles Bibliográficos
Autores principales: Mcgowan, Ian, Cranston, Ross D., Duffill, Kathryn, Siegel, Aaron, Engstrom, Jarret C., Nikiforov, Alexyi, Jacobson, Cindy, Rehman, Khaja K., Elliott, Julie, Khanukhova, Elena, Abebe, Kaleab, Mauck, Christine, Spiegel, Hans M. L., Dezzutti, Charlene S., Rohan, Lisa C., Marzinke, Mark A., Hiruy, Hiwot, Hendrix, Craig W., Richardson-Harman, Nicola, Anton, Peter A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4420274/
https://www.ncbi.nlm.nih.gov/pubmed/25942472
http://dx.doi.org/10.1371/journal.pone.0125363