HIV-1-infectionPhase 1NCT07055451
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
A Phase 1 study testing B/F/TAF in people with HIV-1-infection, run by Gilead Sciences at 7 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 120 hours
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- B/F/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 Aug 2025to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
South Africa4 sites
Family Centre for Research with Ubuntu (FAMCRU)
Cape Town, 7505
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, 4013
Perinatal HIV Research Unit (PHRU)
Gauteng, 1864
WITS RHI Shandukani Research Centre
Johannesburg, 2001
United States3 sites
Grady Health System - Ponce de Leon Center
Atlanta, Georgia, 30308
Ronald Reagan UCLA Medical Center (inpatient hospital)
Los Angeles, California, 90095
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official 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
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.
- Conditions
- HIV-1-infection
- Being tested
- B/F/TAF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Tablet for oral suspension administered
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Group A of B/F/TAF | Experimental | Full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group A to evaluate a different pharmacokinetic (PK) sampling scheme than Cohort 1 Group B.
Neonate participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. Receives: Drug: B/F/TAF |
| Cohort 1: Group B of B/F/TAF | Experimental | Once enrollment in Cohort 1 Group A is completed, full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group B to evaluate a different PK sampling scheme than Cohort 1 Group A.
Participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth
Measured: First dose date up to 8 Weeks
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth
Measured: First dose date up to 8 Weeks
Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
Measured: Predose up to 72 hours postdose
PK parameters for BIC: AUClast
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
Measured: Predose up to 72 hours postdose
PK parameters for BIC: AUC0-24h
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Measured: Predose up to 24 hours postdose
PK parameters for BIC: Cmax
Cmax is defined as the maximum observed concentration of drug.
Measured: Predose up to 72 hours postdose
PK parameters for BIC: Tmax
Tmax is defined as the time (observed time point) of Cmax.
Measured: Predose up to 72 hours postdose
PK parameters for BIC: Cmin
Cmin is defined as the minimum observed concentration of drug.
Measured: Predose up to 72 hours postdose
PK parameters for BIC: C24h
C24h is defined as the concentration of drug at time 24 hours.
Measured: At 24 hours postdose
PK parameters for BIC: t1/2
t1/2 is defined as the terminal elimination half-life.
Measured: Predose up to 72 hours postdose
PK parameters for BIC: Apparent CL/F
Apparent CL/F is defined as the apparent total body clearance for extravascular administration.
Measured: Predose up to 72 hours postdose
PK parameters for BIC: Apparent Vz/F
Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.
Measured: Predose up to 72 hours postdose
Secondary outcomes (12)
PK Parameters for Emtricitabine (FTC), and Tenofovir (TFV): AUCinf
AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time.
Measured: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: AUClast
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
Measured: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: AUC0-24h
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Measured: Predose up to 24 hours postdose
PK parameters for FTC, TAF, and TFV: Cmax
Cmax is defined as the maximum observed concentration of drug.
Measured: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: Tmax
Tmax is defined as the time (observed time point) of Cmax.
Measured: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: Cmin
Cmin is defined as the minimum observed concentration of drug.
Measured: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: C24h
C24h is defined as the concentration of drug at time 24 hours.
Measured: At 24 hours postdose
PK parameters for FTC, TAF, and TFV: t1/2
t1/2 is defined as the terminal elimination half-life.
Measured: Predose up to 72 hours postdose
PK parameters for FTC and TAF: Apparent CL/F
Apparent CL/F is defined as the apparent total body clearance for extravascular administration.
Measured: Predose up to 72 hours postdose
PK parameters for FTC and TAF: Apparent Vz/F
Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.
Measured: Predose up to 72 hours postdose
Mother/Caregiver Reported Acceptability of B/F/TAF tablet for oral suspension (TOS)
Acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better acceptability.
Measured: First dose date up to 15 days
Mother/Caregiver Reported Palatability of B/F/TAF tablet for oral suspension (TOS)
Palatability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability.
Measured: First dose date up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start12 Aug 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055451
- Sponsor's protocol ID
- GS-US-380-5578
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07055451
- Acronym / sponsor ID
- GS-US-380-5578
- Conditions
- HIV-1-infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Group A of B/F/TAF | Experimental | Drug: B/F/TAFFull-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group A to evaluate a different pharmacokinetic (PK) sampling scheme than Cohort 1 Group B. Neonate participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. |
| Cohort 1: Group B of B/F/TAF | Experimental | Drug: B/F/TAFOnce enrollment in Cohort 1 Group A is completed, full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group B to evaluate a different PK sampling scheme than Cohort 1 Group A. Participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. |
Who may qualify
- Ages
- Up to 120 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
- Be born at term (≥ 37.0 weeks gestational age).
- Be able to take oral medication.
- Be ≤ 120 hours of life at enrollment.
Key exclusion criteria (9 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B/F/TAFTablet for oral suspension administered | Drug | Cohort 1: Group A of B/F/TAF, Cohort 1: Group B of B/F/TAF |
Primary outcome
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth
Time frame: First dose date up to 8 Weeks
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth
Time frame: First dose date up to 8 Weeks
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.
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.
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.
PK parameters for BIC: Cmax
Time frame: Predose up to 72 hours postdose
Cmax is defined as the maximum observed concentration of drug.
PK parameters for BIC: Tmax
Time frame: Predose up to 72 hours postdose
Tmax is defined as the time (observed time point) of Cmax.
PK parameters for BIC: Cmin
Time frame: Predose up to 72 hours postdose
Cmin is defined as the minimum observed concentration of drug.
PK parameters for BIC: C24h
Time frame: At 24 hours postdose
C24h is defined as the concentration of drug at time 24 hours.
PK parameters for BIC: t1/2
Time frame: Predose up to 72 hours postdose
t1/2 is defined as the terminal elimination half-life.
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.
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.
12 secondary outcomes
PK Parameters for Emtricitabine (FTC), and Tenofovir (TFV): AUCinf
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: AUClast
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: AUC0-24h
Time frame: Predose up to 24 hours postdose
PK parameters for FTC, TAF, and TFV: Cmax
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: Tmax
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: Cmin
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: C24h
Time frame: At 24 hours postdose
PK parameters for FTC, TAF, and TFV: t1/2
Time frame: Predose up to 72 hours postdose
PK parameters for FTC and TAF: Apparent CL/F
Time frame: Predose up to 72 hours postdose
PK parameters for FTC and TAF: Apparent Vz/F
Time frame: Predose up to 72 hours postdose
Mother/Caregiver Reported Acceptability of B/F/TAF tablet for oral suspension (TOS)
Time frame: First dose date up to 15 days
Mother/Caregiver Reported Palatability of B/F/TAF tablet for oral suspension (TOS)
Time frame: First dose date up to 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing B/F/TAF in people with HIV-1-infection, run by Gilead Sciences at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth (time frame: First dose date up to 8 Weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.