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）.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Hubei
-
Wuhan, Hubei, Chiny, 430071
- Zhongnan Hospital of Wuhan University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
B/F/TAF
Pregnant women who will be exposed to B/F/TAF in the first trimester.
|
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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of Participants with HIV RNA <50 Copies/mL at 12 Weeks of Pregnancy
Ramy czasowe: 12 weeks of pregnancy.
|
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).
|
12 weeks of pregnancy.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maternal Plasma HIV RNA Level
Ramy czasowe: 28 weeks of pregnancy, at delivery, and 2-12 weeks postpartum
|
HIV RNA levels are measured in copies/mL.
Descriptive statistics (geometric mean, median, and interquartile range) will be reported at each specified time point.
|
28 weeks of pregnancy, at delivery, and 2-12 weeks postpartum
|
|
Number of Participants with Treatment-Emergent Grade 3 or 4 Adverse Events
Ramy czasowe: From enrollment through 12 weeks postpartum
|
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.
|
From enrollment through 12 weeks postpartum
|
|
Occurrence of Congenital Anomalies
Ramy czasowe: From birth through 12 weeks postpartum
|
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.
|
From birth through 12 weeks postpartum
|
|
Pregnancy Outcome: Live Birth vs. Fetal Loss/Stillbirth
Ramy czasowe: At delivery
|
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.
|
At delivery
|
|
Infant APGAR Score
Ramy czasowe: At 1 minute and 5 minutes after delivery
|
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.
|
At 1 minute and 5 minutes after delivery
|
|
Number of Infants with Confirmed Positive HIV RNA Test Result
Ramy czasowe: From birth through 12 weeks of age
|
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.
|
From birth through 12 weeks of age
|
|
Infant Weight
Ramy czasowe: At delivery
|
Infant weight is measured in grams at the time of delivery.
Descriptive statistics (mean, standard deviation, median, range) will be reported.
|
At delivery
|
|
Infant Length
Ramy czasowe: At delivery
|
Infant length is measured in centimeters at the time of delivery.
Descriptive statistics (mean, standard deviation, median, range) will be reported.
|
At delivery
|
|
Results of Neonatal Cardiac Ultrasound
Ramy czasowe: At delivery
|
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.
|
At delivery
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- CO-US-380-7588
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .