Pregnant Women Living with HIV on Bictegravir/Emtricitabine/Tenofovir Alafenamide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study analyzes real-world use of the B/F/TAF single-tablet regimen in pregnant women with HIV-1 across six countries. Part 1 describes how the regimen is started, switched, and the characteristics of treated pregnancies when B/F/TAF was used for at least 30 days. Part 2 examines outcomes in women who were on B/F/TAF before conception and had viral suppression in the first trimester, including whether they continued treatment or switched and the resulting viral, pregnancy, and neonatal outcomes. Data are collected retrospectively from HIV treatment centers and obstetric units to reflect routine clinical practice. The study does not include a comparative effectiveness analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Part 1:

1. Women aged ≥18 years with documented HIV-1 infection
2. Having at least one documented pregnancy during the study period
3. Pregnancies with estimated conception date between January 1st 2018 and March 1st 2024
4. Having received B/F/TAF for ≥30 days during pregnancy
5. Having received HIV care at participating sites

   Part 2:
6. Receiving B/F/TAF before conception
7. Demonstrated VS in first trimester (≥ 1 result of HIV-1 plasma viral load \<50 copies/ml and no result ≥50 after achieving VS available before 14 weeks gestation)

Exclusion Criteria:

1. Women who do not consent to having their data collected for research purposes
2. Receiving B/F/TAF with other ARVs simultaneously

Where it's running

• Hôpital Pitié-Slapêtrière
  Paris, France Recruiting

Study contacts

• Study coordinator: Pierre Frange, Professor
• Email: pierre.frange@aphp.fr
• Phone: +33 0144494961

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.