a multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1% tenofovir gel多级,单个和多个剂量药代动力学研究的阴道候选人杀菌剂1%替诺福韦凝胶.pdfVIP
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a multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1% tenofovir gel多级,单个和多个剂量药代动力学研究的阴道候选人杀菌剂1%替诺福韦凝胶
A Multi-Compartment, Single and Multiple Dose
Pharmacokinetic Study of the Vaginal Candidate
Microbicide 1% Tenofovir Gel
1 2¤a 3 4 5¤b
Jill L. Schwartz *, Wes Rountree , Angela D. M. Kashuba , Vivian Brache , Mitchell D. Creinin , Alfred
Poindexter6, Brian P. Kearney7
1 CONRAD, Eastern Virginia Medical School (EVMS), Arlington, Virginia, United States of America, 2 Family Health International (FHI), Research Triangle Park, North
Carolina, United States of America, 3 University of North Carolina Eshelman School of Pharmacy and University of North Carolina CFAR Clinical Pharmacology and
Analytical Chemistry Core Laboratory, University of North Carolina, Chapel Hill, North Carolina, United States of America, 4 PROFAMILIA, Santo Domingo, Dominican
Republic, 5 Center for Family Planning Research, University of Pittsburgh and Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America,
6 Advances in Health, Inc., Houston, Texas, United States of America, 7 Gilead Sciences, Foster City, California, United States of America
Abstract
Background: Tenofovir (TFV) gel is being evaluated as a microbicide with pericoital and daily regimens. To inhibit viral
replication locally, an adequate concentration in the genital tract is critical.
Methods and Findings: Forty-nine participants entered a two-phase study: single-dose (SD) and multi-dose (MD), were
randomized to collection of genital tract samples (endocervical cells [ECC], cervicovaginal aspirate and vaginal biopsies) at
one of seven time points [0.5, 1, 2, 4, 6, 8, or 24 hr(s)] post-dose following SD exposure of 4 mL 1% TFV gel and received a
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