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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...
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. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2015
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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 |
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