B/F/TAF for HIV

Not currently recruiting at 28 trial locations

Overseen By Gilead Study Team

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Gilead Sciences

Must be taking: Antiretrovirals

Disqualifiers: HIV resistance, Low eGFR, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a combination of three medications—Bictegravir, Emtricitabine, and Tenofovir Alafenamide—works in the body and assesses its safety for children and teens living with HIV-1. The study aims to determine the best dose and evaluate how well the treatment is tolerated. Suitable candidates for this trial include children or teens who have lived with HIV-1 and maintained a stable treatment routine for at least six months, meeting specific weight and age criteria. As a Phase 2, Phase 3 trial, this study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to significant advancements in HIV-1 treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants should be on a stable antiretroviral regimen for at least 6 months before joining. If you are taking nevirapine or efavirenz, you should have stopped at least 14 days before enrolling.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) is generally safe for people with HIV. Studies have found that this treatment is well-tolerated over 48 weeks, with most patients not experiencing severe side effects. In one study, 93.8% of patients achieved successful results, reducing their HIV levels to very low levels.

Another study confirmed its effectiveness and safety over 12 months, with no major health issues reported. B/F/TAF is already used for adults with HIV, providing some confidence in its safety. However, like any treatment, some side effects may occur, but serious problems are rare. Always consult a doctor about any concerns or questions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

Unlike the standard HIV treatments, which typically involve multiple pills, the B/F/TAF combination offers a single-tablet regimen. This combination includes Bictegravir, which is a newer integrase inhibitor, along with Emtricitabine and Tenofovir Alafenamide. Bictegravir is known for its strong potency and high barrier to resistance, making it a standout choice. Researchers are excited about this treatment because it simplifies the daily regimen for patients and has a favorable side effect profile, potentially improving adherence and overall patient outcomes.

What evidence suggests that this treatment might be an effective treatment for HIV?

Research has shown that the combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) effectively treats HIV. In one study, 92% of participants with HIV showed positive results after 12 months of treatment. Another study found that almost all participants had their HIV levels in the blood under control after 24 weeks. Additionally, this treatment is generally well-tolerated, with few side effects reported. Overall, B/F/TAF offers a strong option for effectively managing HIV. Participants in this trial will receive B/F/TAF in various dosages based on age and weight, as part of different study cohorts. ^{2 5 6 7 8}

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 children and adolescents with HIV-1 who have been virologically suppressed for at least 6 months. It includes different age groups: those aged 12 to <18 years weighing ≥35 kg, those aged 6 to <12 years weighing ≥25 kg, and younger children down to infants of ≥1 month old with varying weight requirements. Participants must have a stable antiretroviral regimen, good kidney function (eGFR ≥90 mL/min/1.73 m^2), and no resistance to certain HIV medications.

Inclusion Criteria

I have been on a stable HIV medication regimen for at least 6 months.

My HIV does not resist common medications like FTC, TFV, or INSTIs.

I am a child with HIV, either new to treatment or have been on ARV for at least a month.

Exclusion Criteria

Other protocol defined Inclusion/Exclusion criteria may apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive B/F/TAF FDC tablets for oral suspension once daily through Week 48

48 weeks

Intensive PK evaluation at Week 2

Open-label extension

Participants in countries where B/F/TAF is not available may continue to receive the treatment until it becomes available

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

Trial Overview The study tests various doses of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in fixed dose combinations for safety and how the body processes them. The goal is also to confirm the appropriate dosing for these age groups while monitoring their response to this combination therapy.

How Is the Trial Designed?

Group I: Open-Label Extension Experimental Treatment 3 Interventions

Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.

Group II: Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg) Experimental Treatment 1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group III: Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg) Experimental Treatment 1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group IV: Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg) Experimental Treatment 1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group V: Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg) Experimental Treatment 1 Intervention

Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2. Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) once daily through Week 48.

Group VI: Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg) Experimental Treatment 1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48.

Group VII: Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg) Experimental Treatment 1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48.

Group VIII: Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg) Experimental Treatment 1 Intervention

* Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48.

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

Published Research Related to This Trial

In a study involving 631 treatment-naive adults with HIV-1, the fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide was found to be non-inferior to the combination of dolutegravir, abacavir, and lamivudine at week 96, with 88% of participants achieving undetectable HIV-1 RNA levels.

Bictegravir was associated with fewer adverse events compared to dolutegravir, with only 28% of participants reporting drug-related side effects, and no participants discontinuing treatment due to adverse events, highlighting its safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Wohl, DA., Yazdanpanah, Y., Baumgarten, A., et al.[2022]

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) demonstrated high efficacy in maintaining HIV-1 suppression, with 98.6% of participants achieving HIV-1 RNA levels below 50 copies/mL after 240 weeks of treatment.

The treatment was found to be safe, with only 1.6% of participants discontinuing due to adverse events, and no cases of treatment-emergent resistance were detected, indicating its long-term durability and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. Sax, PE., Arribas, JR., Orkin, C., et al.[2023]

In a 48-week study involving 86 older adults with HIV, switching to the medication bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) resulted in a high rate of virologic suppression, with 90.7% of participants maintaining HIV-1 RNA levels below 50 copies/ml.

The treatment was well tolerated, with no serious adverse events related to the drug and a high adherence rate of 98.6%, indicating that B/F/TAF is a safe and effective option for older adults living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial. Maggiolo, F., Rizzardini, G., Molina, JM., et al.[2021]

In a 96-week study involving 86 older adults (≥65 years) living with HIV, switching to the treatment B/F/TAF maintained high rates of viral suppression, with 94.2% of participants remaining virologically suppressed at week 72 and 74.4% at week 96.

The treatment was found to be safe, with no serious drug-related adverse events and stable CD4 counts, indicating that B/F/TAF is a viable long-term option for older adults with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV: Results of a 96-week, phase 3b, open-label, switch trial in virologically suppressed people ≥65 years of age. Maggiolo, F., Rizzardini, G., Molina, JM., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39564653/

Effectiveness, safety, and patient-reported outcomes of ... Treatment per sistence at 48 weeks was 99.3% (TN) and 99.5% (TE). Virological suppression rates (<200/<50 copies/mL) at 24 weeks were 97.4/88% ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772707625001201

Real-world effectiveness, safety, and health-related quality ... Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) confirmed a high effectiveness of 92% in persons with HIV after 12 months. •. No major mutations ...

3. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf162/8098170

Real-world Effectiveness and Safety of Bictegravir ... Bictegravir combined with emtricitabine and tenofovir alafenamide (BIC/FTC/TAF) has shown high effectiveness and a good tolerability profile [5–7], comparable ...

4. link.springer.com link.springer.com/article/10.1007/s40121-025-01153-y

A Pooled Analysis of Studies in People with HIV Outcomes after viremic events were categorized as: virologic resuppression (≥ 1 subsequent VL < 50 copies/mL); continued viremia (all subsequent ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/25787489.2025.2456890

final 24-month effectiveness and safety outcomes in key ... Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), ...

6. 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, ...

7. academic.oup.com academic.oup.com/ofid/article/11/11/ofae630/7826499

Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir ... The BIC/FTC/TAF regimen showed a high virologic suppression rate, with HIV-1 RNA <50 copies/mL at an estimated rate of 93.8% at 48 weeks, similar to results of ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03998176

Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF ... This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected patients who actively use ...