The Women TAF-FTC Benchmark Study
第2/3相
完了
NCT05140954
| 対象疾患 | HIV Infections |
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| 相 | 第2/3相 |
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| スポンサー | University of Washington |
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| ステータス | 完了 |
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| 参加者数 | 54 名 |
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| 介入（薬剤） | co-formulated 25mg TAF/ 200mg FTC |
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| 開始日 | 2023年4月10日 |
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| 完了日 | 2023年12月19日 |
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| 結果公開日 | 2025年10月27日 |
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概要
The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure prophylaxis (PrEP) therapy with tenofovir alafenamide-emtricitabine (TAF-FTC). Cisgender women will be randomly assigned to receive varying frequencies of weekly PrEP doses and followed for up to 18 weeks.These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.
Frequency of Adverse Events
Assessed through the 10 week DOT dosing period · Number of adverse events
| Poor Adherence | 69 Number of adverse events |
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| Moderate Adherence | 60 Number of adverse events |
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| Perfect Adherence | 62 Number of adverse events |
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| Poor Adherence | 1 Number of adverse events |
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| Moderate Adherence | 1 Number of adverse events |
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| Perfect Adherence | 0 Number of adverse events |
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Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Ten Weeks in Dried Blood Spots (DBS)
Assessed at week 10 · fmol/punches
| Poor Adherence | 432 fmol/punches |
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| Moderate Adherence | 1214 fmol/punches |
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| Perfect Adherence | 2345 fmol/punches |
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| Poor Adherence | 261 fmol/punches |
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| Moderate Adherence | 976 fmol/punches |
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| Perfect Adherence | 4031 fmol/punches |
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Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Four Weeks in Peripheral Blood Mononuclear Cells (PBMCs)
Assessed at week 4 · fmol/10^6 cells
| Poor Adherence | 70 fmol/10^6 cells |
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| Moderate Adherence | 229 fmol/10^6 cells |
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| Perfect Adherence | 680 fmol/10^6 cells |
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| Poor Adherence | 407 fmol/10^6 cells |
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| Moderate Adherence | 1859 fmol/10^6 cells |
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| Perfect Adherence | 6402 fmol/10^6 cells |
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