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NCT Number: NCT07055451

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

The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) in neonates exposed to human immunodeficiency virus type 1 (HIV-1).

The primary objective of this study is to evaluate the safety and plasma pharmacokinetics (PK) (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) of B/F/TAF tablet for oral suspension (TOS) in full-term neonates exposed to HIV-1 but uninfected.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV-1-infection

Age range

Up to 120 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Family Centre for Research with Ubuntu (FAMCRU), Cape Town, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Mother inclusion criteria:

  • Be on standard of care (SOC) antiretroviral therapy for human immunodeficiency virus type 1 (HIV-1) treatment.
  • Have confirmed HIV-1 infection based on positive test results obtained from medical records.

Neonate inclusion criteria:

  • Be born at term (≥ 37.0 weeks gestational age).
  • Be able to take oral medication.
  • Be ≤ 120 hours of life at enrollment.
  • Have a birth weight ≥ 2.5 kg.
  • Is receiving or plans to receive HIV-1 SOC prophylaxis regimen with 1 antiretroviral (ARV) to prevent perinatal transmission.

Key Exclusion Criteria:

Mother exclusion criteria:

  • Has a maternal-fetal blood group incompatibility identified by clinically relevant antibody that can cause hemolytic diseases of the neonate.
  • Is breastfeeding or plans to breastfeed while on bictegravir (BIC) or emtricitabine (FTC) containing regimen. Mothers on BIC or FTC containing regimen, but not breastfeeding, can be enrolled in the study.

Neonate exclusion criteria:

  • Had prior or expected to require blood exchange transfusion.
  • Is receiving or plans to receive any component of B/F/TAF or dolutegravir as part of their SOC ARV prophylaxis regimen.
  • Has a documented positive HIV-1 nucleic acid test.
  • Has Grade 2 or higher aspartate aminotransferase, total bilirubin, hemoglobin, platelets or creatinine. Has Grade 1 or higher alanine aminotransferase.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

B/F/TAF

Drug

Tablet for oral suspension administered

Primary outcomes

  1. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth

    Time frame: First dose date up to 8 Weeks

  2. Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth

    Time frame: First dose date up to 8 Weeks

  3. Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf

    Time frame: Predose up to 72 hours postdose

    AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.

  4. PK parameters for BIC: AUClast

    Time frame: Predose up to 72 hours postdose

    AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.

  5. PK parameters for BIC: AUC0-24h

    Time frame: Predose up to 24 hours postdose

    AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.

  6. PK parameters for BIC: Cmax

    Time frame: Predose up to 72 hours postdose

    Cmax is defined as the maximum observed concentration of drug.

  7. PK parameters for BIC: Tmax

    Time frame: Predose up to 72 hours postdose

    Tmax is defined as the time (observed time point) of Cmax.

  8. PK parameters for BIC: Cmin

    Time frame: Predose up to 72 hours postdose

    Cmin is defined as the minimum observed concentration of drug.

  9. PK parameters for BIC: C24h

    Time frame: At 24 hours postdose

    C24h is defined as the concentration of drug at time 24 hours.

  10. PK parameters for BIC: t1/2

    Time frame: Predose up to 72 hours postdose

    t1/2 is defined as the terminal elimination half-life.

  11. PK parameters for BIC: Apparent CL/F

    Time frame: Predose up to 72 hours postdose

    Apparent CL/F is defined as the apparent total body clearance for extravascular administration.

  12. PK parameters for BIC: Apparent Vz/F

    Time frame: Predose up to 72 hours postdose

    Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.

Secondary outcomes

  1. PK Parameters for Emtricitabine (FTC), and Tenofovir (TFV): AUCinf

    Time frame: Predose up to 72 hours postdose

    AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time.

  2. PK parameters for FTC, TAF, and TFV: AUClast

    Time frame: Predose up to 72 hours postdose

    AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.

  3. PK parameters for FTC, TAF, and TFV: AUC0-24h

    Time frame: Predose up to 24 hours postdose

    AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.

  4. PK parameters for FTC, TAF, and TFV: Cmax

    Time frame: Predose up to 72 hours postdose

    Cmax is defined as the maximum observed concentration of drug.

  5. PK parameters for FTC, TAF, and TFV: Tmax

    Time frame: Predose up to 72 hours postdose

    Tmax is defined as the time (observed time point) of Cmax.

  6. PK parameters for FTC, TAF, and TFV: Cmin

    Time frame: Predose up to 72 hours postdose

    Cmin is defined as the minimum observed concentration of drug.

  7. PK parameters for FTC, TAF, and TFV: C24h

    Time frame: At 24 hours postdose

    C24h is defined as the concentration of drug at time 24 hours.

  8. PK parameters for FTC, TAF, and TFV: t1/2

    Time frame: Predose up to 72 hours postdose

    t1/2 is defined as the terminal elimination half-life.

  9. PK parameters for FTC and TAF: Apparent CL/F

    Time frame: Predose up to 72 hours postdose

    Apparent CL/F is defined as the apparent total body clearance for extravascular administration.

  10. PK parameters for FTC and TAF: Apparent Vz/F

    Time frame: Predose up to 72 hours postdose

    Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.

  11. Mother/Caregiver Reported Acceptability of B/F/TAF tablet for oral suspension (TOS)

    Time frame: First dose date up to 15 days

    Acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better acceptability.

  12. Mother/Caregiver Reported Palatability of B/F/TAF tablet for oral suspension (TOS)

    Time frame: First dose date up to 15 days

    Palatability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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