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Study Comparing Integrase Inhibitor (Bictegravir) and Boosted Protease Inhibitor (Darunavir) Treatments for Patients with Advanced HIV Infection

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 treatments for people with advanced HIV infection. The study is comparing two different types of medications used to treat HIV. One group of participants will receive a treatment called Symtuza, which is a combination of four substances: emtricitabine, tenofovir alafenamide, darunavir, and cobicistat. The other group will receive a treatment called Biktarvy, which combines emtricitabine, tenofovir alafenamide, and bictegravir. The purpose of the study is to see if the treatment with an integrase inhibitor, like Biktarvy, is as effective or better than a boosted protease inhibitor, like Symtuza, for patients with advanced HIV.

Participants in the study will take their assigned medication in the form of film-coated tablets, which are taken orally. The study will last for a period of 48 weeks, during which time participants will be monitored to see how well the medication works in controlling the virus and improving their immune system. The study will also look at the safety and tolerability of the medications, which means checking for any side effects or reactions to the treatment. Throughout the study, the health and progress of the participants will be closely observed to gather information on how the treatments affect their HIV infection.

The study aims to provide valuable insights into the effectiveness of these two treatment options for people with advanced HIV. By comparing the two medications, researchers hope to determine which treatment might be more beneficial for patients who are starting therapy later in the course of their disease. This information could help guide future treatment decisions for people living with HIV.

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

    Joining the study

    Upon joining the study, the patient must provide informed consent, confirming understanding of the study requirements and willingness to comply with them.

    Eligibility criteria include being 18 years or older, having HIV-1 infection, and being able to take oral medications.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the patient's health status, including a CD4 cell count and HIV viral load measurement.

    The patient must have a CD4 cell count below 200 cells per microliter and an HIV viral load greater than 1000 copies per milliliter.

  3. Step 3

    Treatment assignment

    The patient is randomly assigned to one of two treatment groups: one receiving an integrase inhibitor regimen and the other a boosted protease inhibitor regimen.

    The integrase inhibitor regimen includes Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, tenofovir alafenamide 25 mg) taken orally as a film-coated tablet.

    The boosted protease inhibitor regimen includes Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg) taken orally as a film-coated tablet.

  4. Step 4

    Treatment duration

    The treatment is administered daily for a duration of 48 weeks.

    Regular monitoring of the patient's health status, including CD4 cell count and HIV viral load, is conducted throughout the treatment period.

  5. Step 5

    Follow-up assessments

    Follow-up assessments occur at weeks 4, 8, 12, 24, 36, and 48 to evaluate the patient's response to treatment.

    These assessments include measuring the proportion of patients with an HIV-RNA viral load below 50 copies per milliliter and monitoring any side effects or complications.

  6. Step 6

    End of study evaluation

    At the end of the 48-week period, a final evaluation is conducted to assess the overall effectiveness and safety of the treatment.

    The study aims to determine whether the integrase inhibitor regimen is superior or equivalent to the boosted protease inhibitor regimen.

Who can join the trial?

10 criteria

  • Must be able to understand and sign a written informed consent form, which means agreeing to participate in the study and following all the study requirements.
  • Must be at least 18 years old.
  • Must have **HIV-1 infection** and meet one of the following conditions:
    • Have **AIDS** but not have active **tuberculosis (TB)** or **cryptococcal meningitis** with any **CD4 cell count**.
    • Have a severe **bacterial infection** and a **CD4 cell count** less than 200 cells per microliter within 28 days before joining the study.
    • Have any symptoms or no symptoms with a **CD4 cell count** less than 100 cells per microliter within 28 days before joining the study and an **HIV viral load** greater than 1000 copies per milliliter.
    • Currently being treated for **opportunistic infections**, which are infections that occur more often or are more severe in people with weakened immune systems.
    • Must have an **HIV viral load** greater than 1000 copies per milliliter.
    • Must be able to take medications by mouth.
    • Must not have taken **antiretroviral therapy (ART)** before joining the study.
    • Must be willing to use acceptable methods of contraception to prevent pregnancy during the study.

Who cannot join the trial?

1 criterion

  • Patients who have been diagnosed with **HIV-1** (Human Immunodeficiency Virus) infection at a late stage.
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Investigated drugs

  • Integrase Inhibitor

    is a type of medication used in the treatment of HIV. It works by blocking the integrase enzyme, which is necessary for the virus to replicate and integrate its genetic material into the host's DNA. This helps to reduce the amount of virus in the body and improve the immune system's function.

  • Boosted Protease Inhibitor

    is another type of medication used to treat HIV. It inhibits the protease enzyme, which the virus needs to process its proteins and replicate. The "boosted" part refers to the addition of another drug that enhances the effectiveness of the protease inhibitor, allowing it to work better in controlling the virus.

What is already known about the treatment

  • Integrase Inhibitor

    This medication is administered orally and is used in the treatment of advanced HIV infection. It is currently being studied in clinical trials to compare its effectiveness against boosted protease inhibitors. The main therapeutic indication is for patients with advanced HIV-1. At the molecular level, integrase inhibitors work by blocking the HIV integrase enzyme, which is essential for the viral replication process. They belong to the pharmacological class of antiretroviral drugs.

  • Boosted Protease Inhibitor

    This medication is also administered orally and is used in the management of advanced HIV infection. It is part of ongoing clinical trials to evaluate its efficacy compared to integrase inhibitors. The primary therapeutic use is for patients with advanced HIV-1. The mechanism of action involves inhibiting the protease enzyme, which is crucial for the maturation of infectious viral particles. Boosted protease inhibitors are classified as antiretroviral drugs.

Investigated diseases

HIV-1 Infection – HIV-1 is a virus that attacks the immune system, specifically targeting CD4 cells, which are crucial for fighting infections. As the virus replicates, it reduces the number of these cells, weakening the immune system over time. Initially, individuals may experience flu-like symptoms, but as the infection progresses, they may become asymptomatic for years. Without treatment, the immune system becomes severely compromised, leading to increased susceptibility to opportunistic infections and certain cancers. The progression of the disease is monitored by measuring the viral load and CD4 cell count. Advanced stages of the infection can lead to Acquired Immunodeficiency Syndrome (AIDS), characterized by a very low CD4 count and the presence of specific opportunistic infections or cancers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505167-36-00Protocol codeNEAT44Estimated enrolment447 patientsSponsorNEAT ID Foundation

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