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GS5578: Biktarvy in Newborns Exposed to HIV

About this study

Over 1 million infants globally are born each year to mothers living with human immunodeficiency virus (HIV) infection. A mother living with HIV can pass the virus to her baby during pregnancy, childbirth, or through breastfeeding. HIV infection in exposed infants may be prevented by giving HIV medications to the mother and infant.

Biktarvy® is a medicine approved by the U.S. Food and Drug Administration (FDA) to treat HIV. It combines 3 medicines—bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF)—into 1 pill. The company that makes Biktarvy is studying a pill that can be dissolved in water. This would allow it to be given to infants and children too young to swallow pills.

This study is the first to use Biktarvy in infants. Researchers will study how safe the medicine is for babies, how their bodies process it, and what dose works best. Information from this study may lead to FDA approval of this medicine in infants; it would be the first once-daily HIV medication for infants.

Babies born to mothers living with HIV will enroll within 5 days of birth and remain in the study until 8 weeks of age. In this initial version of the study (Cohort 1), infants will receive 1 dose of Biktarvy at Visit 1 (within 5 days of birth) and a second dose 10–15 days later. 

Babies will have blood drawn for labs to make sure their bodies are tolerating the medicine. They will also have blood draws for levels of the drug (“PK levels”). 

Mothers will also answer questions about how their babies like the taste of the medicine and how easily they swallow it.

What we learn from this study may help improve HIV prevention and treatment for newborns in the future, giving more babies a healthy start in life.

Eligibility overview

  • Full-term newborn (at least 37 weeks gestational age at birth)
  • Birth weight at least 2.5 kg (5.5 pounds)
  • Up to 120 hours old
  • Will receive only 1 medicine (zidovudine) as standard of care prophylaxis for prevention of HIV infection from their mothers
  • If breastfed, the infant’s mother cannot be taking Biktarvy herself 

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

GS5578: A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Neonates Exposed to HIV-1

Study goal:

To study if Biktarvy® is safe for newborns who were born to mothers living with HIV, how this medicine moves through the body, and what dose works best.

Diagnosis:

HIV

Age:

Up to 120 hours at enrollment

Clinical trials categories:

Human Immunodeficiency Virus (HIV) Infection Infectious Diseases

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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