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Part 1: Document Description
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Citation |
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Title: |
A Randomized, Phase 1, Open-Label Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety and Bleeding Patterns Associated with 90-Day Use of Matrix Vaginal Rings Containing 200 mg Dapivirine and 320 mg |
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Identification Number: |
doi:10.7910/DVN/VZLUFP |
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Distributor: |
Harvard Dataverse |
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Date of Distribution: |
2024-09-27 |
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Version: |
1 |
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Bibliographic Citation: |
Friedland, Barbara; Gundacker, Holly, 2024, "A Randomized, Phase 1, Open-Label Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety and Bleeding Patterns Associated with 90-Day Use of Matrix Vaginal Rings Containing 200 mg Dapivirine and 320 mg", https://doi.org/10.7910/DVN/VZLUFP, Harvard Dataverse, V1 |
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Citation |
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Title: |
A Randomized, Phase 1, Open-Label Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety and Bleeding Patterns Associated with 90-Day Use of Matrix Vaginal Rings Containing 200 mg Dapivirine and 320 mg |
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Identification Number: |
doi:10.7910/DVN/VZLUFP |
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Authoring Entity: |
Friedland, Barbara (Population Council) |
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Gundacker, Holly (SCHARP) |
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Distributor: |
Harvard Dataverse |
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Access Authority: |
Plagianos, Marlena |
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Depositor: |
Warn, Debra |
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Date of Deposit: |
2024-09-25 |
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Holdings Information: |
https://doi.org/10.7910/DVN/VZLUFP |
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Study Scope |
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Keywords: |
Medicine, Health and Life Sciences, dapivirine, levonorgestrel, vaginal ring, MPT, acceptability, adherence |
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Abstract: |
IPM, which was acquired by the Population Council in 2022, is the developer of the dapivirine vaginal ring and a multipurpose prevention technology (MPT) vaginal ring containing dapivirine and levonorgestrel. Two Phase 1 trials, evaluating pharmacokinetics, safety, bleeding patterns, acceptability, adherence and the vaginal microenvironment of the dapivirine levonorgestrel ring were conducted at sites in the United States by the Microbicide Trials Network (MTN). The data sets shared here support the bleeding and acceptability analyses from one of the clinical trials (MTN-044). |
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Time Period: |
2018-07-2019-10 |
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Country: |
United States |
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Geographic Coverage: |
Pennsylvania, Pittsburgh, University of Pittsburgh |
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Unit of Analysis: |
Participant |
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Kind of Data: |
Quantitative |
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Notes: |
The data dictionaries summarize all data from clinical trial, some of which are not shared here. Only data supportive of the reference publication are shared. |
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Methodology and Processing |
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Type of Research Instrument: |
Case report forms, questionnaires, daily text messages |
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Sources Statement |
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Data Access |
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Other Study Description Materials |
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Related Publications |
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Citation |
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Title: |
Achilles SL, Kelly CW, Hoesley CJ, Blithe DL, Brown J, Richardson BA, et al. (2024) Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings. PLoS ONE 19(6): e0304552. https://doi.org/10.1371/journal.pone.0304552 |
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Bibliographic Citation: |
Achilles SL, Kelly CW, Hoesley CJ, Blithe DL, Brown J, Richardson BA, et al. (2024) Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings. PLoS ONE 19(6): e0304552. https://doi.org/10.1371/journal.pone.0304552 |
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Label: |
20190610_MTN044_aCRFs_Version_4.0.pdf |
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Notes: |
application/pdf |
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20210219_MTN044_READ-ME_IntroDataStructure_IPM_V2.0.pdf |
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Notes: |
application/pdf |
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ce.sas7bdat |
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application/x-sas-system |
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cebld.sas7bdat |
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application/x-sas-system |
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dm.sas7bdat |
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application/x-sas-system |
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ds.sas7bdat |
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application/x-sas-system |
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dstrt.sas7bdat |
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application/x-sas-system |
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ec1.sas7bdat |
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application/x-sas-system |
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ecth.sas7bdat |
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application/x-sas-system |
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ecthyn.sas7bdat |
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application/x-sas-system |
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enr.sas7bdat |
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application/x-sas-system |
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m044_bleed.sas7bdat |
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Notes: |
application/x-sas-system |
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mtn-044_v2.0_7june2018_protocol.pdf |
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Notes: |
application/pdf |
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qs1.sas7bdat |
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application/x-sas-system |
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qs2.sas7bdat |
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application/x-sas-system |
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qs3.sas7bdat |
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Notes: |
application/x-sas-system |
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Tables S1S2_dissemination.pdf |
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Notes: |
application/pdf |