Article
A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study).
PloS one - 1 Jan 2015
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
Abstract excerpt
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 RMP-02/MTN-006 Phase 1 rectal safety study. The reduced glycerin VF (RGVF) gel was used in the MTN-007 Phase 1...
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