Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)
Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for HIV Pre-Exposure Prophylaxis (PrEP): A Pooled Observational Study
This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure prophylaxis (PrEP). All individuals were enrolled and followed as described in the parent PrEP demonstration project or clinical study protocol until study completion, HIV-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring.
In the protocols of the parent PrEP observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, renal and bone adverse events, and HIV-1 infection status. Adherence was determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol.
Gilead had collected data from 21 global PrEP demonstration projects and clinical studies for over 7,000 Truvada for PrEP users who had at least one measurement of adherence. Data from the different contributing studies were pooled for statistical analyses by Gilead.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Foster City、California、美国、94404
- Gilead Sciences, Inc.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Participants in an FTC/TDF for PrEP observational or clinical study
- HIV-1 negative individual at the time of enrollment in a demonstration project or clinical study
- Participants with at least one measurement of tenofovir-diphosphate (TFV-DP) in dried blood spot (DBS) or tenofovir (TFV) in plasma
Exclusion Criteria:
- This is an observational study and will collect HIV-1 infection and resistance information along with renal or skeletal adverse events without intervention.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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FTC/TDF for PrEP
HIV-1 negative adults (any sex/gender, including transgender, pregnancy) who are participating in observational or clinical studies on FTC/TDF for PrEP
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP
大体时间：Baseline to Year 3
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Baseline to Year 3
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment
大体时间：Baseline to Year 3
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The time to onset of signs and/or symptoms if acute HIV infection in relation to exposure to study drug will be recorded.
Signs and symptoms include fever, lymphadenopathy, pharyngitis, rash, myalgia, malaise, mouth and esophageal sores, and may also include, but less commonly, headache, nausea and vomiting, enlarged liver/spleen, weight loss, thrush, and neurological symptoms.
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Baseline to Year 3
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Time to seroconversion during treatment
大体时间：Baseline to Year 3
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The time to seroconversion in relation to exposure to study drug will be recorded.
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Baseline to Year 3
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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