HIVNCT07666386
Safety and Efficacy of B/F/TAF in Pregnancy
An observational study of HIV, run by Shi Zou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- BIC+FTC+TAF
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2026to 30 Jun 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with HIV who receiving B/F/TAF for at least 6 months, virus suppressed (VS) for more than 6 months and who are in first trimester.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Pregnant Women With HIV Infection（BIP STUDY）.
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- BIC+FTC+TAF
- Keywords
- HIV, pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIC+FTC+TAFDrug
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
| Study group | Role | What they receive |
|---|---|---|
| B/F/TAF | Pregnant women who will be exposed to B/F/TAF in the first trimester. Receives: Drug: BIC+FTC+TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with HIV RNA <50 Copies/mL at 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).
Measured: 12 weeks of pregnancy.
Secondary outcomes (9)
Maternal Plasma HIV RNA Level
HIV RNA levels are measured in copies/mL. Descriptive statistics (geometric mean, median, and interquartile range) will be reported at each specified time point.
Measured: 28 weeks of pregnancy, at delivery, and 2-12 weeks postpartum
Number of Participants with Treatment-Emergent Grade 3 or 4 Adverse Events
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.
Measured: From enrollment through 12 weeks postpartum
Occurrence of Congenital Anomalies
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.
Measured: From birth through 12 weeks postpartum
Pregnancy Outcome: Live Birth vs. Fetal Loss/Stillbirth
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.
Measured: At delivery
Infant APGAR Score
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.
Measured: At 1 minute and 5 minutes after delivery
Number of Infants with Confirmed Positive HIV RNA Test Result
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.
Measured: From birth through 12 weeks of age
Infant Weight
Infant weight is measured in grams at the time of delivery. Descriptive statistics (mean, standard deviation, median, range) will be reported.
Measured: At delivery
Infant Length
Infant length is measured in centimeters at the time of delivery. Descriptive statistics (mean, standard deviation, median, range) will be reported.
Measured: At delivery
Results of Neonatal Cardiac Ultrasound
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.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start9 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shi Zou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Zou, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666386
- Sponsor's protocol ID
- CO-US-380-7588
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Pregnant Women With HIV Infection（BIP STUDY）.
- ClinicalTrials.gov ID
- NCT07666386
- Acronym / sponsor ID
- CO-US-380-7588
- Conditions
- HIV
- Keywords
- HIV, pregnant women
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shi ZouUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B/F/TAF | – | Drug: BIC+FTC+TAFPregnant women who will be exposed to B/F/TAF in the first trimester. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with HIV who receiving B/F/TAF for at least 6 months, virus suppressed (VS) for more than 6 months and who are in first trimester.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIC+FTC+TAFParticipants 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 | Drug | B/F/TAF |
Primary outcome
Proportion of Participants with HIV RNA <50 Copies/mL at 12 Weeks of Pregnancy
Time frame: 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).
9 secondary outcomes
Maternal Plasma HIV RNA Level
Time frame: 28 weeks of pregnancy, at delivery, and 2-12 weeks postpartum
Number of Participants with Treatment-Emergent Grade 3 or 4 Adverse Events
Time frame: From enrollment through 12 weeks postpartum
Occurrence of Congenital Anomalies
Time frame: From birth through 12 weeks postpartum
Pregnancy Outcome: Live Birth vs. Fetal Loss/Stillbirth
Time frame: At delivery
Infant APGAR Score
Time frame: At 1 minute and 5 minutes after delivery
Number of Infants with Confirmed Positive HIV RNA Test Result
Time frame: From birth through 12 weeks of age
Infant Weight
Time frame: At delivery
Infant Length
Time frame: At delivery
Results of Neonatal Cardiac Ultrasound
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Shi Zou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with HIV RNA <50 Copies/mL at 12 Weeks of Pregnancy (time frame: 12 weeks of pregnancy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.