Safety and Efficacy of B/F/TAF in Pregnancy

NCT07666386 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: CO-US-380-7588
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV

Keywords

HIV; pregnant women

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks of pregnancy.

Secondary Outcomes (9)

• Maternal Plasma HIV RNA Level

  28 weeks of pregnancy, at delivery, and 2-12 weeks postpartum

• Number of Participants with Treatment-Emergent Grade 3 or 4 Adverse Events

  From enrollment through 12 weeks postpartum

• Occurrence of Congenital Anomalies

  From birth through 12 weeks postpartum

• Pregnancy Outcome: Live Birth vs. Fetal Loss/Stillbirth

  At delivery

• Infant APGAR Score

  At 1 minute and 5 minutes after delivery

Study Arms (1)

B/F/TAF

Pregnant women who will be exposed to B/F/TAF in the first trimester.

Drug: BIC+FTC+TAF

Interventions

BIC+FTC+TAF DRUG

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

B/F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shi Zou: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 24, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)