B/F/TAF for HIV

Recruiting at 4 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Gilead Sciences

Must be taking: Antiretrovirals

Must not be taking: B/F/TAF, Dolutegravir

Disqualifiers: Blood transfusion, Positive HIV-1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 72 hours postdose

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the medication B/F/TAF (Bictegravir/Emtricitabine/Tenofovir Alafenamide) is processed and tolerated in newborns exposed to HIV-1 but not infected. Researchers are evaluating the safety and pharmacokinetics of the drug in full-term, healthy newborns born to mothers with HIV-1. Ideal participants are newborns who are at least 37 weeks gestational age, weigh at least 2.5 kg, and can take oral medication, alongside mothers undergoing HIV-1 treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if the neonate is already receiving any component of B/F/TAF or dolutegravir, they cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the medication Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) is generally safe for children aged 2 years and older. Studies have found it effective for treating HIV-1 in these age groups, with common side effects being mild, such as headache, nausea, and diarrhea. Although information for newborns is limited, evidence from older children suggests it is safe. Additionally, the FDA has already approved B/F/TAF for treating HIV-1 in adults and older children, supporting its safety. This study aims to learn more about how newborns handle and respond to the drug. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) because it combines three potent antiretrovirals into a single, fixed-dose tablet, simplifying treatment for HIV. Unlike other treatments that may require multiple pills or separate doses, B/F/TAF offers a streamlined approach that could improve adherence, especially important for mothers and their newborns. Additionally, B/F/TAF is designed to reduce side effects, potentially offering a better safety profile compared to some existing options. This makes B/F/TAF a promising candidate for postnatal prophylaxis in babies exposed to HIV, aiming to protect them effectively and conveniently from the virus.

What evidence suggests that B/F/TAF might be an effective treatment for HIV?

Research has shown that the combination of drugs Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) effectively treats HIV-1 in adults. Studies demonstrate that it helps control the virus in the body. This drug combination works similarly to other main treatments for managing HIV. In adults, B/F/TAF has been compared to other therapies and has shown positive results in real-world use. In this trial, Cohort 1 Group A and Cohort 1 Group B will evaluate different pharmacokinetic sampling schemes of B/F/TAF in full-term neonates exposed to HIV-1 but uninfected. Although limited data exists on newborns, the individual components of B/F/TAF have been used safely in different groups. These findings suggest it could be effective and safe for preventing HIV in newborns exposed to the virus but not infected. ^{1 3 5 6 7}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for newborns born at full term (≥37 weeks), weighing ≥2.5 kg, and are ≤120 hours old at enrollment. They must be able to take oral medication, be on standard HIV-1 care or prophylaxis with one antiretroviral drug, and have confirmed exposure to HIV but not infected.

Inclusion Criteria

I am enrolling within 5 days of my expected end of life.

I was born weighing at least 2.5 kg.

I was born at or after 37 weeks of pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Neonate participants receive a single dose of B/F/TAF fixed-dose combination tablet for oral suspension along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3

Up to 72 hours postdose

2 visits (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics of the study drug

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bictegravir/Emtricitabine/Tenofovir Alafenamide

Trial Overview The study tests Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in tablet form for newborns exposed to HIV. It aims to assess the safety of B/F/TAF and how it's processed by a baby's body (pharmacokinetics).

How Is the Trial Designed?

Group I: Cohort 1: Group B of B/F/TAF Experimental Treatment 1 Intervention

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.

Group II: Cohort 1: Group A of B/F/TAF Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07055451

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in ... 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 ...

2. academic.oup.com academic.oup.com/cid/article/81/4/e93/8098170

Real-world Effectiveness and Safety of Bictegravir ... This study compares bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) with other first-line antiretroviral therapies in treatment-naive adults.

3. gileadclinicaltrials.com gileadclinicaltrials.com/study?nctid=NCT07055451

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in ... The primary objective of this study is to evaluate the safety and plasma pharmacokinetics (PK) (how B/F/TAF is absorbed, modified, distributed, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693755/

Bictegravir/Emtricitabine/Tenofovir Alafenamide for HIV-1 This review presents recent literature supporting the use of B/F/TAF as an option for consolidating therapy and maintaining virologic suppression.

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/210251Orig1s000OtherR.pdf

210251Orig1s000 - accessdata.fda.gov Conduct a study to evaluate the pharmacokinetics and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in neonates (birth to ...

6. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/bictegravir

Pediatric Antiretroviral Drug Information - Bictegravir | NIH Pharmacokinetics and safety of coformulated bictegravir, emtricitabine, and tenofovir alafenamide in children aged 2 years and older with ...

7. ema.europa.eu ema.europa.eu/en/documents/product-information/biktarvy-epar-product-information_en.pdf

Biktarvy, INN-bictegravir / emtricitabine / tenofovir alafenamide There are limited safety and efficacy data for Biktarvy in patients co-infected with HIV-1 and hepatitis C virus (HCV). Biktarvy contains tenofovir alafenamide, ...