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Study of Bictegravir and Lenacapavir for Children and Adolescents with HIV-1

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of HIV-1 infection in children and adolescents. The study will use a combination of two medications: Bictegravir and Lenacapavir. These medications are provided in the form of film-coated tablets. Bictegravir is also known by the code name GS-9883, and Lenacapavir is sometimes referred to as GS-6207 or GS-CA1. The purpose of the study is to evaluate how these medications work together in the body, their safety, and their ability to fight the virus in young people living with HIV-1.

Participants in the study will take the medications orally, meaning they will swallow the tablets. The study will last for a period of time, during which the participants will be monitored to see how their bodies respond to the treatment. The study will also look at how well the medications are tolerated by the participants, which means checking for any side effects or reactions to the treatment. The study aims to ensure that the combination of Bictegravir and Lenacapavir is both safe and effective for children and adolescents with HIV-1.

Throughout the study, the participants' health will be closely observed, and their response to the treatment will be assessed. This includes measuring the levels of the virus in their blood and checking for any changes in their immune system. The study will also gather feedback from participants about how they feel about taking the medication, including its taste and ease of use. The goal is to confirm the appropriate dosage and ensure the treatment is suitable for young people with HIV-1.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Blood tests are performed to ensure specific health criteria are met, such as adequate kidney function and normal blood cell counts.

  2. Step 2

    Medication administration

    Participants begin taking the study medications, which include bictegravir and lenacapavir. These are provided in the form of film-coated tablets.

    The dosage for bictegravir is 75 mg, and for lenacapavir, it is 50 mg. These are taken orally as a fixed-dose combination tablet.

  3. Step 3

    Loading dose phase

    An initial loading dose of lenacapavir is administered to establish the appropriate drug levels in the body. This phase is crucial for achieving the desired therapeutic effect.

  4. Step 4

    Regular follow-up visits

    Participants attend regular follow-up visits to monitor health and response to the medication. These visits include physical examinations and laboratory tests.

    The frequency of these visits is determined by the study protocol and may vary over the course of the trial.

  5. Step 5

    Safety and efficacy evaluation

    Throughout the study, the safety and effectiveness of the medications are evaluated. This includes monitoring for any side effects and assessing the control of HIV-1 levels in the blood.

    Participants' experiences with the medication, including its acceptability and palatability, are also assessed through questionnaires.

  6. Step 6

    End of study procedures

    At the conclusion of the study, final assessments are conducted to evaluate the overall impact of the treatment.

    Participants may be offered continued access to the medication or referred to alternative treatment options, depending on the study's findings and recommendations.

Who can join the trial?

17 criteria

  • The participant's parent, guardian, or legally authorized representative must be willing and able to provide written consent before any study procedures begin.
  • If the participant is lactating, they must agree to stop nursing before taking the study drugs.
  • The participant should be willing and able to provide written agreement to participate, if possible, according to local guidelines and regulations.
  • The participant must be within the following age and weight groups at screening:
    • Cohort 1: 12 to less than 18 years old, weighing at least 35 kg.
    • Cohort 2: 6 to less than 12 years old, weighing 25 kg to less than 35 kg.
    • Cohort 3: 2 to less than 6 years old, weighing 10 kg to less than 25 kg.
    • The participant must be on a complex antiretroviral (ARV) regimen, which means taking more than one tablet or any other formulation a day.
    • The participant must have documented plasma HIV-1 RNA levels of less than 50 copies/mL (or undetectable levels according to the local test used) in the last 6 months before screening, with at least one measurement before screening.
    • The participant's plasma HIV-1 RNA levels must be less than 50 copies/mL at screening.
    • The participant must not have any documented or suspected resistance to integrase strand transfer inhibitors (INSTIs), which are specific mutations in the HIV virus.
    • The participant must meet the following laboratory parameters at screening:
      • Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m², which is a measure of kidney function.
      • Absolute neutrophil count greater than 0.50 cells/L (greater than 500 cells/mm³), which is a type of white blood cell count.
      • Hemoglobin level of at least 85 g/L (greater than 8.5 g/dL), which is a measure of red blood cells.
      • Platelet count of at least 50 cells/L (at least 50,000 cells/mm³), which are cells that help with blood clotting.
      • Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) levels should be no more than 5 times the upper limit of normal, which are liver enzymes.
      • Total bilirubin level of no more than 23 µmol/L (no more than 1.5 mg/dL) and direct bilirubin level of no more than 7 µmol/L (no more than 0.4 mg/dL), which are measures of liver function.
      • Participants assigned female at birth who are of childbearing potential must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1.

Who cannot join the trial?

3 criteria

  • Individuals who do not have HIV-1 infection cannot participate. HIV-1 infection is a type of virus that affects the immune system.
  • Children and adolescents who are not within the specified age range for the study cannot participate. The study is for a specific age group.
  • Participants who are not considered part of the vulnerable population selected for the study cannot participate. A vulnerable population may include groups that need special protection.
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Investigated drugs

  • Bictegravir

    is a medication used to treat HIV-1 infection. It works by blocking an enzyme that the virus needs to multiply, helping to reduce the amount of virus in the body. This can improve the immune system and decrease the chance of developing HIV-related illnesses.

  • Lenacapavir

    is another medication used in the treatment of HIV-1. It helps to prevent the virus from multiplying by interfering with its ability to assemble and mature. This can help control the infection and improve the patient's health.

What is already known about the treatment

  • Bictegravir

    Bictegravir is administered orally and is currently being studied in clinical trials for its effectiveness in treating HIV-1 infection. It is an integrase inhibitor, which means it works by blocking the HIV virus from integrating its genetic material into the host's DNA, a crucial step in the virus's replication process. This medication is part of a combination therapy aimed at reducing the viral load in patients. It is still under investigation to confirm its safety and optimal dosing in children and adolescents.

  • Lenacapavir

    Lenacapavir is also administered orally and is under clinical investigation for its use in treating HIV-1 infection. It acts by inhibiting the capsid protein of the HIV virus, which is essential for the virus's ability to replicate and assemble new viral particles. Lenacapavir is being studied for its potential to be part of a long-acting treatment regimen, offering a new approach to managing HIV-1. The current research focuses on its pharmacokinetics, safety, and antiviral activity in younger populations.

Investigated diseases

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4 cells. Over time, the virus reduces the number of these cells, weakening the body's ability to fight infections and diseases. Initially, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without intervention, the infection can advance to acquired immunodeficiency syndrome (AIDS), characterized by a severely compromised immune system. The progression of the disease varies among individuals, influenced by factors such as viral load and immune response. Regular monitoring of viral load and CD4 cell counts is essential to understand the progression of the infection.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IVTrial ID2023-509428-16-00Protocol codeGS-US-621-6463Estimated enrolment74 patientsSponsorGilead Sciences Inc.

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