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Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

Researching medication effects in newborns exposed to HIV.

Recruiting
120 years and younger
All
Phase 1

This study is for newborns exposed to HIV-1, a virus that affects the immune system. Researchers want to see how safe and effective a medication called Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) is for these babies. They're also studying how the medicine moves through the body, which is called pharmacokinetics (PK). Babies in this study should be born at full-term (after 37 weeks of pregnancy), weigh at least 2.5 kg (about 5.5 pounds), and be able to take medicine by mouth. Mothers need to be on a standard HIV treatment and not breastfeeding if they are on a B/F/TAF regimen. Babies cannot join if they have certain medical conditions or if they've already been exposed to parts of the study medication.

  • Must be born at full-term and weigh at least 2.5 kg.
  • Study checks how the medicine is absorbed and works in the body.
  • Mothers should not breastfeed while on certain medications.
Study details
    HIV-1-infection

NCT07055451

Gilead Sciences

7 March 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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