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）.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Hubei
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Wuhan、Hubei、中国、430071
- Zhongnan Hospital of Wuhan University
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants with HIV RNA <50 Copies/mL at 12 Weeks of Pregnancy
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maternal Plasma HIV RNA Level
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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