Safety and Efficacy of B/F/TAF in Pregnancy
Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Pregnant Women With HIV Infection（BIP STUDY）.
研究概览
详细说明
Statistical Methods Descriptive statistics will be used to summarize the data. Continuous variables will be presented as means with standard deviations and medians with interquartile ranges, depending on the distribution of the data. Categorical variables will be described by their frequency distribution and ranges (Two-sided 95% confidence).
Efficacy:
The proportion of participants with plasma HIV RNA <50 copies/mL at the time of delivery will be summarized using the missing = excluded approach for imputing missing HIV RNA values.
Safety:
The adverse events (AE) data will be listed by subject. Treatment-emergent AEs, Grade 1-4 AEs will be summarized by system organ class, and preferred term using the current version of the Medical Dictionary for Regulatory Activities (MedDRA), and graded according to the DIADS Table for Grading the Severity of Adult and Pediatric Adverse Events .
Listings of individual subject vital signs, 12-lead ECG parameters, and laboratory results will be provided. Laboratory abnormalities will be graded for severity using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Laboratory results and changes from baseline for vital signs and selected lab tests will be summarized at scheduled visits. The incidence and grade of treatment-emergent laboratory abnormalities will be summarized accordingly.
Maternal/neonatal outcomes analysis Proportion of infants with confirmed negative or positive HIV RNA testing will be summarized using the missing = excluded approach for imputing missing HIV RNA values.
Proportion of live births, stillbirths, and pregnancy loss will be summarized. APGAR scores will be summarized. Adverse events and toxicity management
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events:
Adverse Events An AE is any untoward medical occurrence in a clinical study subject administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also include lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure.
研究类型
注册 (估计的)
联系人和位置
学习地点
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Hubei
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Wuhan、Hubei、中国、430071
- Zhongnan Hospital of Wuhan University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Women with aged 18 years or older and confirmed HIV infection.
- Currently on B/F/TAF for 6 months preceding the screening visit.
- Documented plasma HIV RNA<50 copies/mL for 6 months preceding the screening visit and have HIV RNA<50 copies/mL at the screening visit.
- Women within 12 weeks of pregnancy at the time of screening.
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Exclusion Criteria:
- Have active hepatitis C virus (HCV) infection.
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening.
- Other clinical scenarios that are no longer suitable for B/F/TAF therapy (Such as electrocardiogram, liver and kidney dysfunction, opportunistic infection and so on).
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 |
干预/治疗 |
|---|---|
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B/F/TAF
Pregnant women who will be exposed to B/F/TAF in the first trimester.
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Participants who are on B/F/TAF for at least 6 months, virus suppressed (VS) for more than 6 months and who are in first trimester
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of Participants with HIV RNA <50 Copies/mL at 12 Weeks of Pregnancy
大体时间：12 weeks of pregnancy.
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The proportion is calculated using the Missing=Excluded approach (participants with missing HIV RNA values at the 12-week time point are excluded from both numerator and denominator).
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12 weeks of pregnancy.
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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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Maternal Plasma HIV RNA Level
大体时间：28 weeks of pregnancy, at delivery, and 2-12 weeks postpartum
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HIV RNA levels are measured in copies/mL.
Descriptive statistics (geometric mean, median, and interquartile range) will be reported at each specified time point.
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28 weeks of pregnancy, at delivery, and 2-12 weeks postpartum
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Number of Participants with Treatment-Emergent Grade 3 or 4 Adverse Events
大体时间：From enrollment through 12 weeks postpartum
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Adverse events are graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Only events that are treatment-emergent (occurring or worsening after study drug initiation) and of Grade 3 or 4 severity are reported.
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From enrollment through 12 weeks postpartum
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Occurrence of Congenital Anomalies
大体时间：From birth through 12 weeks postpartum
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Congenital anomalies are identified through prenatal ultrasound examinations, prenatal diagnostics (e.g., amniocentesis with genetic/epigenetic testing), and postnatal physical examination.
Each anomaly is reported as a separate event.
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From birth through 12 weeks postpartum
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Pregnancy Outcome: Live Birth vs. Fetal Loss/Stillbirth
大体时间：At delivery
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Pregnancy outcomes are categorized as live birth, fetal loss (spontaneous abortion <20 weeks), or stillbirth (fetal death ≥20 weeks).
The proportion of each category will be reported.
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At delivery
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Infant APGAR Score
大体时间：At 1 minute and 5 minutes after delivery
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APGAR score is assessed at 1 and 5 minutes post-delivery.
Scores range from 0 to 10, with higher scores indicating better condition.
If asphyxia is present, an additional assessment is performed at 10 minutes.
Descriptive statistics (mean, standard deviation, median, range) will be reported for each time point.
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At 1 minute and 5 minutes after delivery
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Number of Infants with Confirmed Positive HIV RNA Test Result
大体时间：From birth through 12 weeks of age
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HIV RNA testing is performed at birth, 6 weeks of age, and 12 weeks of age.
A confirmed positive result requires two consecutive positive tests.
Infants with negative or indeterminate results at all time points are considered uninfected.
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From birth through 12 weeks of age
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Infant Weight
大体时间：At delivery
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Infant weight is measured in grams at the time of delivery.
Descriptive statistics (mean, standard deviation, median, range) will be reported.
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At delivery
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Infant Length
大体时间：At delivery
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Infant length is measured in centimeters at the time of delivery.
Descriptive statistics (mean, standard deviation, median, range) will be reported.
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At delivery
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Results of Neonatal Cardiac Ultrasound
大体时间：At delivery
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Cardiac ultrasound is performed on the neonate at delivery.
Findings are categorized as normal, abnormal-minor finding not requiring intervention, or abnormal-major finding requiring further evaluation or intervention.
The number and proportion of infants in each category will be reported.
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At delivery
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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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