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Study Comparing Two Drug Regimens for HIV: Lamivudine and Dolutegravir Sodium vs. Emtricitabine, Tenofovir Alafenamide, and Bictegravir in HIV-Positive Patients

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, which stands for human immunodeficiency virus. The study compares two different medication regimens for managing HIV. One group of participants will receive Dovato, which contains the active substances lamivudine and dolutegravir sodium. The other group will receive Biktarvy, which includes emtricitabine, tenofovir alafenamide, and bictegravir (also known as GS-9883). The purpose of the study is to evaluate the effectiveness of these treatments in maintaining low levels of the virus in the body.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will last for a total of 240 weeks, with regular check-ups and assessments at various intervals, such as weeks 48, 144, and 240. During these visits, blood samples will be collected to measure the amount of HIV in the blood and to assess the function of the immune system. The study will also monitor other health markers, including metabolic and cardiovascular health, to ensure the safety and effectiveness of the treatments.

The trial aims to demonstrate that the two-drug regimen of Dovato is not inferior to the three-drug regimen of Biktarvy in terms of controlling the virus. This means that the study will check if the simpler two-drug treatment is just as effective as the more complex three-drug treatment. Participants will be closely monitored throughout the study to ensure their well-being and to gather important data on the long-term management of HIV.

The research process

The trial runs in 5 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, you will be asked to provide written consent, confirming your willingness to participate and your understanding of the study's requirements.

    You will need to confirm that you are at least 18 years old and that you have been on a specific HIV treatment with HIV RNA levels below 50 copies/mL for at least three months.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to collect baseline data. This includes blood samples to measure various health markers and to store for future research purposes.

    You will be required to attend scheduled visits and assessments throughout the study duration.

  3. Step 3

    Medication administration

    You will be randomly assigned to one of two medication regimens: Biktarvy or Dovato.

    Biktarvy consists of emtricitabine, tenofovir alafenamide, and bictegravir, taken as a 50 mg/200 mg/25 mg film-coated tablet once daily by mouth.

    Dovato consists of lamivudine and dolutegravir sodium, taken as a 50 mg/300 mg film-coated tablet once daily by mouth.

  4. Step 4

    Ongoing assessments

    Throughout the study, you will undergo regular assessments at specified weeks: baseline, week 24, week 48, week 72, week 96, week 120, week 144, week 186, week 192, week 216, and week 240.

    These assessments will include blood tests to measure viral markers, immune cell function, and metabolic parameters.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the long-term effects of the medication regimen.

    This will include a comprehensive analysis of cardiovascular risk and other health markers.

Who can join the trial?

6 criteria

  • Must be 18 years or older.
  • Must be able and willing to provide written informed consent. This means you agree to participate in the study after being fully informed about it.
  • Must be able to attend all scheduled assessments and visits required by the study.
  • Must be able and willing to have blood samples collected and stored for research purposes.
  • Must have HIV RNA levels (a measure of the virus in your blood) less than 50 copies/mL for at least 3 months while on a specific type of HIV medication called a 2nd generation integrase inhibitor (INSTI).
  • Females of childbearing potential must be using effective contraception to prevent pregnancy during the study.

Who cannot join the trial?

5 criteria

  • Individuals who do not have a diagnosis of HIV (Human Immunodeficiency Virus).
  • Individuals who are not within the specified age range for the study.
  • Individuals who are not part of the specified clinical trial groups.
  • Individuals who are not male or female, as both genders are included in the study.
  • Individuals who are not considered part of a vulnerable population.
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Investigated drugs

  • Dovato

    is a medication used in the treatment of HIV. It combines two active ingredients, dolutegravir and lamivudine, which work together to help control the HIV virus in the body. Dolutegravir helps prevent the virus from multiplying, while lamivudine helps reduce the amount of virus in the blood. This combination helps improve the immune system and reduces the risk of developing HIV-related illnesses.

  • Biktarvy

    is another medication used to treat HIV. It contains three active ingredients: bictegravir, emtricitabine, and tenofovir alafenamide. Bictegravir helps block the virus from multiplying, while emtricitabine and tenofovir alafenamide work together to lower the amount of virus in the blood. This combination helps strengthen the immune system and decreases the chance of HIV-related complications.

What is already known about the treatment

  • Dovato

    Dovato is a medication taken orally in the form of tablets, used to treat human immunodeficiency virus (HIV) infection. It is currently recognized in medical literature as a two-drug regimen (2DR) and is being studied for its effectiveness compared to a three-drug regimen (3DR) in managing HIV. The main therapeutic indication for Dovato is to help control HIV infection, which can improve the immune system and reduce the risk of HIV-related complications. At the molecular level, Dovato works by inhibiting the replication of the virus, thus reducing the amount of virus in the body. It is classified pharmacologically as an antiretroviral medication.

  • Biktarvy

    Biktarvy is an oral medication in tablet form, used for the treatment of human immunodeficiency virus (HIV) infection. It is well-documented in medical literature as a three-drug regimen (3DR) and is being compared to a two-drug regimen (2DR) in clinical trials for its effectiveness in managing HIV. The primary therapeutic use of Biktarvy is to control HIV infection, which helps improve immune function and decrease the risk of HIV-related health issues. Biktarvy works at the molecular level by preventing the virus from multiplying, thereby lowering the viral load in the body. It is classified as an antiretroviral medication.

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 appear. 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 ID2024-515265-34-00Protocol code2DR-study (Rumba)Estimated enrolment134 patientsSponsorUniversitair Ziekenhuis Gent

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