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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Pubblicato in:PLoS One
Autori principali: 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.
Natura: Artigo
Lingua:Inglês
Pubblicazione: Public Library of Science 2015
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Research Article
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC4420274/
https://ncbi.nlm.nih.gov/pubmed/25942472
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1371/journal.pone.0125363
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