75 Participants Needed

Bictegravir + Lenacapavir for HIV

Recruiting at 21 trial locations
GC
Overseen ByGilead Clinical Study Information Center
Age: < 18
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Gilead Sciences
Must be taking: Complex ARV regimen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in virologically suppressed (VS) children and adolescents with human immunodeficiency virus type 1 (HIV-1) on a stable and complex antiretroviral (ARV) regimen. The study will also assess the safe loading dose of LEN and pharmacokinetics (PK) of BIC/LEN.The primary objectives of this study are:* To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BIC/LEN FDC in VS children and adolescents with HIV-1.* To evaluate the safety and tolerability of BIC/LEN through Week 24 in VS children and adolescents with HIV-1.

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 Bictegravir + Lenacapavir safe for humans?

Bictegravir, a component of Biktarvy, is generally well tolerated in humans, with common side effects including diarrhea, nausea, and headache. Real-world studies have shown higher rates of adverse effects and discontinuation compared to clinical trials, but it is considered safe for treating HIV. There is no specific safety data available for the combination of Bictegravir and Lenacapavir.12345

What makes the drug Bictegravir/Lenacapavir unique for treating HIV?

Bictegravir/Lenacapavir is unique because it combines two potent components: bictegravir, a novel integrase strand transfer inhibitor (INSTI) with high resistance to mutations, and lenacapavir, which is being explored for its potential long-acting effects. This combination aims to provide a more resilient and possibly longer-lasting treatment option for HIV compared to existing therapies.13467

What data supports the effectiveness of the drug Bictegravir/Lenacapavir for HIV?

Bictegravir, a component of Biktarvy, has been shown to be effective in treating HIV-1 infection, both in patients new to treatment and those switching therapies, with studies indicating it is as effective as other similar drug combinations. It is recommended as a preferred treatment option in HIV guidelines due to its high barrier to resistance and limited drug interactions.12378

Who Is on the Research Team?

GS

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

My HIV-1 RNA levels have been undetectable or very low in the last 6 months.
Plasma HIV-1 RNA levels < 50 copies/mL at screening
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)
See 2 more

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.
See 6 more

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?
3Treatment groups
Experimental Treatment
Group I: Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kgExperimental Treatment2 Interventions
Group II: Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kgExperimental Treatment2 Interventions
Group III: Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDCExperimental Treatment2 Interventions

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

🇺🇸
Approved in United States as Biktarvy (bictegravir component) for:
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Approved in European Union as Biktarvy (bictegravir component) for:
🇺🇸
Approved in United States as Sunlenca (lenacapavir component) for:
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Approved in European Union as Sunlenca (lenacapavir component) for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

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

Citations

Bictegravir: First Global Approval. [2022]
Efficacy, safety and tolerability of Biktarvy in HIV-1 infection: A scoping review. [2023]
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. [2022]
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. [2021]
Biktarvy for the treatment of HIV infection: Progress and prospects. [2023]
Human and nonclinical disposition of [14C]bictegravir, a potent integrase strand-transfer inhibitor for the treatment of HIV-1 infection. [2023]
Bictegravir, a novel integrase inhibitor for the treatment of HIV infection. [2021]
[Effectiveness, safety, and economic impact of the bictegravir/emtricitabine/tenofovir alafenamide regimen in real clinical practice cohort of HIV-1 infected adult patients]. [2021]
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