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Open Access
Peer-reviewed
Research Article
Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings
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Sharon L. Achilles ,
Roles Conceptualization, Investigation, Methodology, Project administration, Resources, Supervision, Visualization, Writing – original draft, Writing – review & editing
* E-mail: sla40@pitt.edu
Current address: Bill & Melinda Gates Foundation, Seattle, Washington, United States of America
Affiliations Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America
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Clifton W. Kelly,
Roles Formal analysis, Methodology, Software, Validation, Visualization, Writing – original draft, Writing – review & editing
Affiliation Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Craig J. Hoesley,
Roles Investigation, Methodology, Resources, Supervision, Writing – review & editing
Affiliation University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States of America
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Diana L. Blithe,
Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing
Affiliation National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America
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Jill Brown,
Roles Methodology, Supervision, Writing – review & editing
Current address: Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States of America
Affiliation National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America
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Barbra A. Richardson,
Roles Conceptualization, Formal analysis, Investigation, Methodology, Supervision, Writing – review & editing
Affiliations Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America, Department of Biostatistics, University of Washington, Seattle, Washington, United States of America
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Brid Devlin,
Roles Resources, Writing – review & editing
Affiliation International Partnership for Microbicides, Silver Spring, Maryland, United States of America
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Craig W. Hendrix,
Roles Formal analysis, Investigation, Methodology, Validation, Writing – review & editing
Affiliation Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America
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Samuel M. Poloyac,
Roles Methodology, Validation, Writing – review & editing
Current address: University of Texas at Austin, College of Pharmacy, Austin, Texas, United States of America
Affiliation Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America
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Mark A. Marzinke,
Roles Formal analysis, Investigation, Methodology, Supervision, Validation, Writing – review & editing
Affiliation Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America
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Holly Gundacker,
Roles Formal analysis, Methodology, Supervision, Validation, Writing – review & editing
Affiliation Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America
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Devika Singh,
Roles Investigation, Supervision, Writing – review & editing
Affiliation Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America
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Jeanna M. Piper,
Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing
Affiliation National Institutes of Allergy and Infectious Disease, NIH, Bethesda, Maryland
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Sherri Johnson,
Roles Methodology, Project administration, Supervision, Writing – review & editing
Affiliation FHI 360, Durham, North Carolina, United States of America
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John Steytler,
Roles Resources, Writing – review & editing
Affiliation International Partnership for Microbicides, Silver Spring, Maryland, United States of America
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Beatrice A. Chen,
Roles Conceptualization, Investigation, Methodology, Project administration, Resources, Supervision, Writing – review & editing
Affiliations Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America
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on behalf of the MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network
¶Membership of the MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trails Network and the Contraceptive Clinical Trials Network is provided in the Acknowledgments
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Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings
- Sharon L. Achilles,
- Clifton W. Kelly,
- Craig J. Hoesley,
- Diana L. Blithe,
- Jill Brown,
- Barbra A. Richardson,
- Brid Devlin,
- Craig W. Hendrix,
- Samuel M. Poloyac,
- Mark A. Marzinke
![PLOS](/resource/img/logo-plos.png)
- Published: June 5, 2024
- https://doi.org/10.1371/journal.pone.0304552