Pre-clinical development of a combination microbicide vaginal ring containing dapivirine and darunavir
نویسندگان
چکیده
منابع مشابه
Microbicide vaginal rings: Technological challenges and clinical development.
Vaginal rings (VRs) are flexible, torus-shaped, polymeric devices designed to sustain delivery of pharmaceutical drugs to the vagina for clinical benefit. Following first report in a 1970 patent application, several steroid-releasing VR products have since been marketed for use in hormone replacement therapy and contraception. Since 2002, there has been growing interest in the use of VR technol...
متن کاملThe sheep as a model of preclinical safety and pharmacokinetic evaluations of candidate microbicides.
When developing novel microbicide products for the prevention of HIV infection, the preclinical safety program must evaluate not only the active pharmaceutical ingredient but also the product itself. To that end, we applied several relatively standard toxicology study methodologies to female sheep, incorporating an assessment of the pharmacokinetics, safety, tolerability, and local toxicity of ...
متن کاملCharacteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention
INTRODUCTION Women in sub-Saharan Africa are a priority population for evaluation of new biomedical HIV-1 prevention strategies. Antiretroviral pre-exposure prophylaxis is a promising prevention approach; however, clinical trials among young women using daily or coitally-dependent products have found low adherence. Antiretroviral-containing vaginal microbicide rings, which release medication ov...
متن کاملPost-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence
Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female...
متن کاملIncreased Dapivirine Tissue Accumulation through Vaginal Film Codelivery of Dapivirine and Tenofovir
The HIV-1 replication inhibitor dapivirine (DPV) is one of the most promising drug candidates being used in topical microbicide products for prevention of HIV-1 sexual transmission. To be able to block HIV-1 replication, DPV must have access to the viral reverse transcriptase enzyme. The window for DPV to access the enzyme happens during the HIV-1 cellular infection cycle. Thus, in order for DP...
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ژورنال
عنوان ژورنال: Journal of Antimicrobial Chemotherapy
سال: 2014
ISSN: 0305-7453,1460-2091
DOI: 10.1093/jac/dku160