{"id":"https://openalex.org/W2332543450","doi":"https://doi.org/10.1097/qai.0000000000000897","title":"A Phase 1 Trial to Assess the Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics of a Novel Dapivirine Vaginal Film","display_name":"A Phase 1 Trial to Assess the Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics of a Novel Dapivirine Vaginal Film","publication_year":2015,"publication_date":"2015-11-13","ids":{"openalex":"https://openalex.org/W2332543450","doi":"https://doi.org/10.1097/qai.0000000000000897","mag":"2332543450","pmid":"https://pubmed.ncbi.nlm.nih.gov/26565716","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/5040830"},"language":"en","primary_location":{"id":"doi:10.1097/qai.0000000000000897","doi":"https://doi.org/10.1097/qai.0000000000000897","is_oa":false,"landing_page_url":"https://doi.org/10.1097/qai.0000000000000897","pdf_url":null,"source":{"id":"https://openalex.org/S157460402","display_name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","issn_l":"1525-4135","issn":["1525-4135","1944-7884"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-140","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/5040830","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5007070381","display_name":"Katherine E. 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Jackson Foundation for the Advancement of Military Medicine, Inc., Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Rockville, MD.; *Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA; Accepted October 26, 2015; Presented in part at the Conference on Retroviruses and Opportunistic Infections, Boston, MA, Abstract #42LB, February 2014.; Received June 22, 2015; Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jaids.com).; Supported by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Grant AI082639 and UL1 TR000005. This project has also been funded in part with federal funds from the National Institute of Allergies and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272200800014C. The International Partnership for Microbicides was the regulatory sponsor of the trial and donated dapivirine drug substance for the films and the dapivirine gel used in this study. The vaginal placebo gel was donated by CONRAD.; The authors have no funding or conflicts of interest to disclose.; \u00a7Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; \u00b6International Partnership for Microbicides, Silver Spring, MD; \u2016Alpha StatConsult, Damascus, MD; \u2020Magee-Womens Research Institute, Pittsburgh, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"*Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA; \u2020Magee-Womens Research Institute, Pittsburgh, PA; \u2021Department of Pharmaceutical Sciences, University of Pittsburgh, Pittsburgh, PA; \u00a7Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; \u2016Alpha StatConsult, Damascus, MD; \u00b6International Partnership for Microbicides, Silver Spring, MD; and #HJF-DAIDS, a Division of The Henry M. 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This project has also been funded in part with federal funds from the National Institute of Allergies and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272200800014C. The International Partnership for Microbicides was the regulatory sponsor of the trial and donated dapivirine drug substance for the films and the dapivirine gel used in this study. 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This project has also been funded in part with federal funds from the National Institute of Allergies and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272200800014C. The International Partnership for Microbicides was the regulatory sponsor of the trial and donated dapivirine drug substance for the films and the dapivirine gel used in this study. The vaginal placebo gel was donated by CONRAD.; The authors have no funding or conflicts of interest to disclose.; \u00a7Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; \u00b6International Partnership for Microbicides, Silver Spring, MD; \u2016Alpha StatConsult, Damascus, MD; \u2020Magee-Womens Research Institute, Pittsburgh, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"","institution_ids":[]},{"raw_affiliation_string":"#HJF-DAIDS, a Division of The Henry M. 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This project has also been funded in part with federal funds from the National Institute of Allergies and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272200800014C. The International Partnership for Microbicides was the regulatory sponsor of the trial and donated dapivirine drug substance for the films and the dapivirine gel used in this study. The vaginal placebo gel was donated by CONRAD.; The authors have no funding or conflicts of interest to disclose.; \u00a7Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; \u00b6International Partnership for Microbicides, Silver Spring, MD; \u2016Alpha StatConsult, Damascus, MD; \u2020Magee-Womens Research Institute, Pittsburgh, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"","institution_ids":[]},{"raw_affiliation_string":"#HJF-DAIDS, a Division of The Henry M. 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