The Women TAF-FTC Benchmark Study
2/3期
已完成
NCT05140954
| 适应症 | HIV Infections |
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| 分期 | 2/3期 |
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| 申办方 | University of Washington |
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| 状态 | 已完成 |
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| 受试者人数 | 54 人 |
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| 干预（药物） | co-formulated 25mg TAF/ 200mg FTC |
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| 开始日期 | 2023年4月10日 |
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| 完成日期 | 2023年12月19日 |
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| 结果公布日 | 2025年10月27日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。