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Study Comparing Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide for HIV Treatment in Adults New to Antiretroviral Therapy

Fast replyRegistered 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, which stands for Human Immunodeficiency Virus. The study is comparing two different medication regimens for adults who have not previously taken antiretroviral therapy, which is the treatment used to manage HIV. The first treatment being studied is a two-drug combination called Dovato, which contains the active substances lamivudine and dolutegravir sodium. The second treatment is a three-drug combination known as Biktarvy, which includes emtricitabine, tenofovir alafenamide, and bictegravir.

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of these two treatment regimens. Participants will be randomly assigned to receive either the two-drug or the three-drug regimen, and they will take their assigned medication once daily. The study will monitor the participants over a period of time to see how well the virus is controlled, as well as to observe any side effects or other health changes that may occur.

Throughout the study, the main goal is to determine if the two-drug regimen is not less effective than the three-drug regimen in controlling the virus in people who are new to antiretroviral therapy. Participants will have regular check-ups and tests to measure the amount of virus in their blood and to assess their overall health. The study aims to provide valuable information on the best treatment options for managing HIV in adults who are starting therapy for the first time.

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

    Enrollment

    Upon joining the study, confirm eligibility by meeting all criteria, including being at least 18 years old, not having taken any antiretroviral therapy before, and providing written informed consent.

    For female participants, a negative pregnancy test is required at the start of the trial.

  2. Step 2

    Initial assessment

    Undergo a baseline assessment to measure initial health status, including HIV-RNA levels and CD4+ cell count.

    This assessment helps in tracking changes over the course of the trial.

  3. Step 3

    Medication administration

    Receive one of two oral medication regimens: Dovato (containing dolutegravir and lamivudine) or Biktarvy (containing bictegravir, emtricitabine, and tenofovir alafenamide).

    Take the assigned medication once daily as a film-coated tablet.

  4. Step 4

    Ongoing monitoring

    Attend regular follow-up visits to monitor health status and medication effects.

    These visits include blood tests to measure HIV-RNA levels and CD4+ cell count at specified intervals, such as Week 48 and Week 96.

  5. Step 5

    Evaluation of outcomes

    The primary goal is to achieve HIV-RNA levels below 50 copies/mL by Week 48.

    Secondary outcomes include maintaining these levels through Week 96 and monitoring any disease progression.

  6. Step 6

    Completion

    Upon completing the trial, a final assessment will be conducted to evaluate overall health and treatment efficacy.

    Participants may receive information on further treatment options based on the trial results.

Who can join the trial?

5 criteria

  • Must be at least 18 years old at the time of giving consent.
  • Can be male or female.
  • If female, must not be pregnant (confirmed by a negative pregnancy test) and must not be breastfeeding.
  • Must have HIV and have not received any treatment for it before (known as being antiretroviral-naïve).
  • Must be able to give written consent to participate in the study.

Who cannot join the trial?

7 criteria

  • People who do not have HIV (Human Immunodeficiency Virus) cannot participate.
  • Individuals who have previously received treatment for HIV are not eligible.
  • Participants must be within the specified age range for the study.
  • Pregnant or breastfeeding women are not allowed to join the study.
  • Individuals with certain medical conditions that could interfere with the study results are excluded.
  • Participants must not be part of any other clinical trial at the same time.
  • People who are unable to follow the study procedures or attend scheduled visits are not eligible.
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Investigated drugs

  • Dolutegravir

    is a medication used to treat HIV. It works by blocking a protein that the virus needs to multiply, helping to lower the amount of virus in the body. This can improve the immune system and reduce the risk of developing HIV-related illnesses.

  • Lamivudine

    is another medication used to treat HIV. It helps to decrease the amount of HIV in the body by interfering with the virus's ability to replicate. This can help improve the immune system and reduce the risk of complications associated with HIV.

  • Bictegravir

    is a medication that helps control HIV infection. It works by preventing the virus from multiplying in the body, which helps to lower the viral load and improve the immune system's function.

  • Emtricitabine

    is used to treat HIV by reducing the amount of virus in the body. It helps to prevent the virus from multiplying, which can improve the immune system and decrease the chance of developing HIV-related health issues.

  • Tenofovir alafenamide

    is a medication that helps manage HIV infection. It works by blocking the virus from multiplying, which helps to lower the viral load and support the immune system in fighting the infection.

What is already known about the treatment

  • Dolutegravir/Lamivudine

    This medication is taken orally in the form of a pill and is used as a first-line treatment for people living with HIV. It is currently being studied in clinical trials to compare its effectiveness and safety to another HIV treatment. The main purpose of this medication is to help control the HIV virus in the body, preventing it from multiplying and reducing the amount of virus in the blood. It works by blocking an enzyme that the virus needs to replicate, helping to maintain a healthy immune system. This medication is classified as an antiretroviral drug.

  • Bictegravir/Emtricitabine/Tenofovir Alafenamide

    This medication is also taken orally as a pill and is used to treat HIV in adults who have not previously received antiretroviral therapy. It is part of a clinical trial to assess its effectiveness compared to another HIV treatment. The medication helps to suppress the HIV virus by interfering with its ability to reproduce, which helps to keep the immune system functioning properly. It belongs to a class of drugs known as antiretrovirals, which are used to manage HIV infection.

Investigated diseases

Human immunodeficiency virus (HIV) – HIV is a virus that attacks the body's immune system, specifically the CD4 cells, which are a type of white blood cell. Over time, HIV can destroy so many of these cells that the body can’t fight off infections and diseases. The virus progresses through several stages, starting with acute infection, where flu-like symptoms may occur. This is followed by a chronic stage, where the virus multiplies at lower levels and may not cause symptoms. Without intervention, HIV can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely damaged. The progression of the disease can vary greatly among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504993-40-00Protocol code219816Estimated enrolment508 patientsSponsorViiv Healthcare UK Limited

sourced from the EU Clinical Trials Register and site verification

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