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HIV drug B/F/TAF tested in pregnancy for safety and virus control

NCT ID NCT07666386

Disease control Sponsor: Shi Zou Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the safety and effectiveness of the HIV medication B/F/TAF in pregnant women who have had their virus under control for at least six months. About 50 women in their first trimester will continue taking the drug through pregnancy and 12 weeks after birth. Researchers will track viral levels, side effects, and health outcomes for both mothers and babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF)
What this could lead to
If successful, this study could provide real-world evidence that B/F/TAF is a safe and effective option for pregnant women with HIV, helping to maintain viral suppression during pregnancy.
What could go wrong
This is an observational study with only 50 participants, so results may not apply to all pregnant women. It does not test a new treatment, and there is always a risk of side effects or loss of viral control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Women with aged 18 years or older and confirmed HIV infection. 2. Currently on B/F/TAF for 6 months preceding the screening visit. 3. 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. 4. Women within 12 weeks of pregnancy at the time of screening. 5. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. Exclusion Criteria: 1. Have active hepatitis C virus (HCV) infection. 2. An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening. 3. 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).

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071, China

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