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）.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Hubei
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Wuhan, Hubei, Porcelana, 430071
- Zhongnan Hospital of Wuhan University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants with HIV RNA <50 Copies/mL at 12 Weeks of Pregnancy
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maternal Plasma HIV RNA Level
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CO-US-380-7588
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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