NCT07666386Enrolling by invitation
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）.
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- Feb 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Shi Zou
- Diseases
- HIV
- NCT number
- NCT07666386
What you commit to
- Study type: Observational
- Planned participants: 50
- From Feb 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening.
Other illness
- Have active hepatitis C virus (HCV) infection.
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.