Bictegravir + Lenacapavir for HIV

Recruiting at 27 trial locations

Overseen By Gilead Clinical Study Information Center

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Gilead Sciences

Must be taking: Complex ARV regimen

Disqualifiers: Low CD4 count, Hepatitis B, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the safety and effectiveness of a new HIV treatment combining bictegravir and lenacapavir (known as Biktarvy and Sunlenca, respectively) in children and adolescents whose HIV is well-controlled on complex medication regimens. Researchers seek to understand how this combination works in the body and its long-term safety. The trial is open to kids and teens who have been on a multi-pill HIV treatment plan and have maintained stable, low virus levels for at least six months.

As a Phase 2, Phase 3 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to potentially groundbreaking HIV treatment advancements.

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 must be on a complex antiretroviral regimen. This suggests you may need to continue your current HIV treatment.

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

Research shows that people generally tolerate the combination of bictegravir and lenacapavir well. Studies have identified the most common side effects as injection site reactions, headaches, and nausea. Importantly, no serious side effects required medical attention. Additionally, many individuals who switched to treatments including bictegravir maintained control of their HIV without major safety issues. These findings suggest that the treatment is safe for most people, though mild side effects might occur. ^{1 2 3 4 5}

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

Researchers are excited about Bictegravir and Lenacapavir for HIV treatment because these drugs offer a unique combination that could streamline therapy. Unlike many standard HIV treatments, which require multiple pills daily, this combo simplifies the regimen with a potential for fewer doses, making it more convenient for patients. Bictegravir is known for its strong barrier to resistance, while Lenacapavir offers a novel mechanism as a capsid inhibitor, which disrupts the virus's ability to replicate. This dual action not only enhances effectiveness but also holds promise for better adherence and long-term outcomes in younger patients.

What evidence suggests that Bictegravir/Lenacapavir might be an effective treatment for HIV?

Research has shown that using bictegravir and lenacapavir together holds promise for treating HIV. This trial will administer a combination of these drugs, known as dual therapy, to effectively combat the virus. One study found that 90% of participants experienced positive results with a daily dose of these drugs. Bictegravir alone has already succeeded for individuals switching from other treatments. Early results suggest this combination might be particularly beneficial for those who have tried other treatments before. Overall, it appears to offer strong protection against HIV. ^{1 2 3 4 5}

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 are virologically suppressed on a complex ARV regimen. It includes three age-based cohorts: 12-18 years weighing ≥35kg, 6-12 years weighing ≥25 to <35kg, and 2-6 years weighing ≥10 to <25kg. Participants must have no resistance to certain HIV medications and meet specific health criteria like adequate neutrophil count and hemoglobin levels.

Inclusion Criteria

Plasma HIV-1 RNA levels < 50 copies/mL at screening

My HIV-1 RNA levels have been undetectable or very low in the last 6 months.

The following laboratory parameters at screening: Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 using the Bedside Schwartz formula, Absolute neutrophil count > 0.50 cells/L (> 500 cells/mm3), Hemoglobin ≥ 85 g/L (> 8.5 g/dL), Platelets ≥ 50 cells/L (≥ 50,000 cells/mm3), Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 x upper limit of normal, Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL)

Exclusion Criteria

CD4 cell count < 200 cells/mm^3

I have not had acute hepatitis in the last 30 days.

I have hepatitis C with detectable virus levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 2-day oral loading dose of LEN, followed by daily oral BIC and LEN dose through Week 48

48 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of BIC/LEN treatment long-term after Week 48

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Bictegravir/Lenacapavir

Trial Overview The study tests the safety, tolerability, and body interaction of a combined drug bictegravir/lenacapavir (BIC/LEN) in children and adolescents with stable but complex anti-HIV treatment regimens. The trial aims to confirm appropriate dosing of LEN as well as understand how BIC/LEN works over time within the body.

How Is the Trial Designed?

Group I: Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg Experimental Treatment 2 Interventions

All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 3 to be defined. Following Week 48, participants will have an option to continue BIC/LEN in the extension period.

Group II: Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg Experimental Treatment 2 Interventions

All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 2 to be defined. Following Week 48, participants will have an option to continue BIC/LEN in the extension period.

Group III: Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDC Experimental Treatment 2 Interventions

Participants will receive a 2-day oral loading dose of LEN (600 mg) on Days 1 and 2 and daily oral BIC/LEN 75/50 mg starting on Day 1 through Week 48. Following Week 48, participants will have an option to continue BIC/LEN in the extension period.

Bictegravir/Lenacapavir is already approved in United States, European Union for the following indications:

Approved in United States as Biktarvy (bictegravir component) for:

• HIV-1 infection treatment in adults

Approved in European Union as Biktarvy (bictegravir component) for:

• HIV-1 infection treatment in adults

Approved in United States as Sunlenca (lenacapavir component) for:

• HIV-1 infection treatment for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection

Approved in European Union as Sunlenca (lenacapavir component) for:

• HIV-1 infection treatment for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection

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

Biktarvy®, a single tablet combining bictegravir, emtricitabine, and tenofovir alafenamide, has shown efficacy in treating both treatment-naïve and virologically suppressed HIV-1 patients, leading to its recent approval in the USA.

The development of bictegravir as an integrase strand transfer inhibitor (INSTI) represents a significant advancement in HIV treatment, providing a convenient fixed-dose option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir: First Global Approval. Markham, A.[2022]

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]

Biktarvy has shown efficacy in real-world clinical practice that is comparable to results from phase III trials, indicating it is effective for treating HIV-1 infection.

However, real-world studies reported higher rates of adverse effects and discontinuation compared to clinical trials, highlighting the need for further research on diverse populations, including women and ethnic minorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety and tolerability of Biktarvy in HIV-1 infection: A scoping review. Peters, E., Iwuji, AC.[2023]

In a study involving 102 virologically suppressed children and adolescents with HIV, the single-tablet regimen of bictegravir, emtricitabine, and tenofovir alafenamide was found to be well tolerated and maintained virological suppression in 98% of participants after 48 weeks.

The pharmacokinetics of bictegravir in children and adolescents were comparable to adults, indicating that this regimen is safe and effective for treating HIV in younger populations, supporting its recommendation as a first-line treatment in the USA for adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide in adolescents and children with HIV: week 48 results of a single-arm, open-label, multicentre, phase 2/3 trial. Gaur, AH., Cotton, MF., Rodriguez, CA., et al.[2021]

Bictegravir (BIC) combined with emtricitabine (FTC) and tenofovir alafenamide (TAF) in the fixed-dose regimen Biktarvy® has been shown to be as effective as other leading HIV treatments, making it a strong option for initial and long-term therapy.

Biktarvy® has a high barrier to drug resistance and limited drug-drug interactions, which enhances its safety profile and makes it a recommended choice in recent HIV treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biktarvy for the treatment of HIV infection: Progress and prospects. De Clercq, E., Zhang, Z., Huang, J., et al.[2023]

In a study of 115 adult HIV patients treated with the antiretroviral regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) for at least 24 weeks, 88% of treatment-naive patients and 94.1% of pretreated patients achieved suppressed plasma viral loads, indicating high efficacy in real-world clinical practice.

The study reported a low incidence of adverse events (7%) among patients, which contrasts with higher rates observed in phase 3 clinical trials, suggesting that BIC/FTC/TAF may be a safer option in routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness, safety, and economic impact of the bictegravir/emtricitabine/tenofovir alafenamide regimen in real clinical practice cohort of HIV-1 infected adult patients]. Gutiérrez-Lorenzo, M., Rubio-Calvo, D., Urda-Romacho, J.[2021]

Bictegravir (BIC) is a highly effective second-generation HIV treatment that shows strong antiviral activity against both wild-type and resistant strains, with virologic suppression rates comparable to first-line therapies in clinical trials.

BIC has a high genetic barrier to resistance, can be taken once daily due to its long half-life of 18 hours, and is generally well tolerated, with only mild side effects like diarrhea, nausea, and headache.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir, a novel integrase inhibitor for the treatment of HIV infection. Zeuli, J., Rizza, S., Bhatia, R., et al.[2021]

Bictegravir (BIC) is a highly effective integrase strand-transfer inhibitor for treating HIV-1, showing rapid absorption and high cumulative dose recovery in both humans (95.3%) and nonclinical species (>80%).

BIC has a favorable pharmacokinetic and metabolic profile, with minimal clinically relevant drug-drug interactions, making it a promising option compared to other integrase inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human and nonclinical disposition of [14C]bictegravir, a potent integrase strand-transfer inhibitor for the treatment of HIV-1 infection. Subramanian, R., Ling, J., Wang, J., et al.[2023]

Citations

1. gilead.com gilead.com/news/news-details/2024/gilead-presents-research-data-across-its-broad-and-innovative-hiv-treatment-portfolio-and-pipeline

Gilead Presents Research Data Across Its Broad and ... Week 48 outcomes presented at AIDS 2024 show that 90% of participants (n=52) treated with once-daily oral bictegravir 75 mg + lenacapavir 50 mg ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10786069/

lenacapavir + bictegravir as a potential treatment for HIV The new combination with bictegravir will be beneficial for treatment experienced patients, as it represents a dual therapy modality with high barriers of ...

3. askgileadmedical.com askgileadmedical.com/docs/biktarvy/biktarvy-efficacy-and-safety-in-hiv-1-infected-virologically-suppressed-participants

Biktarvy® (BIC/FTC/TAF) Efficacy and Safety in HIV-1 ... In virologically suppressed adults infected with HIV-1, switching to BIC/FTC/TAF demonstrated high rates of efficacy compared with staying on the following ...

4. idse.net idse.net/HIV-AIDS/Article/02-25/Promising-Results-HIV-Care-Lenacapavir-and-Bictegravir/76279

Promising Results HIV Care Lenacapavir and Bictegravir Late-breaking clinical data from a pair of studies funded by Gilead Sciences show promising results for products aimed at addressing unmet needs in HIV care.

5. pharmacytimes.com pharmacytimes.com/view/new-data-on-hiv-1-treatments-including-biktarvy-and-novel-lenacapavir-combination-regimen-presented-at-croi-2025

New Data on HIV-1 Treatments, Including Biktarvy and ... Biktarvy demonstrated high virologic suppression rates and ALT normalization in HIV/HBV coinfected patients, indicating its safety and efficacy ...