Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Pregnant Women With HIV Infection（BIP STUDY）.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This is a prospective, multicenter, observational study designed to evaluate the effectiveness and safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in pregnant women living with HIV. Given the limited prospective data on B/F/TAF use during early pregnancy, this study aims to address the evidence gap by observing women who are on B/F/TAF for at least six months with sustained viral suppression (HIV RNA <50 copies/mL) and are within the first trimester. Participants will continue B/F/TAF throughout pregnancy and up to 12 weeks postpartum per routine clinical practice. No experimental intervention will be assigned. The primary objective is to assess the proportion of participants achieving HIV RNA <50 copies/mL at 12 12 weeks of pregnancy. Secondary objectives include maternal viral suppression at 28 weeks, delivery, and postpartum; safety and tolerability; maternal and neonatal outcomes including congenital anomalies, APGAR scores, infant HIV status, and growth parameters. The study will enroll at least 50 participants across five clinical centers in China. Findings will provide real-world evidence on the use of B/F/TAF as an alternative integrase inhibitor-based regimen for pregnant women with HIV.
详细描述
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究者
Shi Zou
associate chief physician
Wuhan University