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Safety and Efficacy of B/F/TAF in Pregnancy

NCT07666386 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-06-24

No results posted yet for this study

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

Interventions

DRUG

BIC+FTC+TAF

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

Sponsors & Collaborators

  • Shi Zou

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666386 on ClinicalTrials.gov