Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effectiveness and Safety of Lamivudine, Dolutegravir Sodium, Cabotegravir, and Rilpivirine for Adults with HIV-1 Who Have Not Taken Antiretroviral Therapy

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 adults who have not previously taken any antiretroviral therapy. The study will use two different treatment approaches. Initially, participants will take a daily oral medication called Dovato, which contains the active substances lamivudine and dolutegravir sodium. After achieving control of the virus, participants will have the option to switch to a long-acting injectable treatment given every two months. This injectable treatment consists of two medications: Vocabria, which contains cabotegravir, and REKAMBYS, which contains rilpivirine.

The purpose of the study is to evaluate how well these treatments work in suppressing the HIV virus in the blood and maintaining this suppression over time. Participants will start with the oral medication to achieve initial control of the virus. Once the virus is under control, they can choose to continue with the oral medication or switch to the injectable treatment. The study will monitor the effectiveness and safety of both treatment options, as well as participants' preferences and experiences with the treatments.

Throughout the study, participants will receive regular check-ups to assess their health and the effectiveness of the treatment. The study aims to provide valuable information on the best ways to manage HIV-1 infection in adults who are new to antiretroviral therapy. Participants will have the opportunity to choose the treatment option that best suits their lifestyle and preferences, while the study gathers important data on the outcomes of these treatments.

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

    Initial treatment phase

    Begin taking Dovato, which contains lamivudine and dolutegravir sodium, as a film-coated tablet.

    Take one tablet orally once a day.

    This phase aims to suppress the HIV virus in the blood.

  2. Step 2

    Monitoring and assessment

    Regular monitoring of HIV viral load to ensure it is less than 50 copies per milliliter.

    Assessments will occur periodically to evaluate the effectiveness of the treatment.

  3. Step 3

    Optional switch to injectable regimen

    After achieving virologic suppression, there is an option to switch to a long-acting injectable regimen.

    This involves receiving Vocabria (cabotegravir) and REKAMBYS (rilpivirine) as intramuscular injections.

    Injections are administered every two months.

  4. Step 4

    Maintenance phase

    Continue with the chosen regimen to maintain virologic suppression.

    Regular follow-ups and assessments will continue to monitor health and treatment effectiveness.

  5. Step 5

    End of study

    The study is expected to conclude by August 2026.

    Final assessments will be conducted to evaluate long-term outcomes and treatment satisfaction.

Who can join the trial?

6 criteria

  • Must be at least 18 years old. In some places, you might need to be older, depending on local rules.
  • Can be male or female. If female, you must not be pregnant, which will be checked with a blood test and a urine test, and you must not be breastfeeding.
  • Must have a certain level of the HIV virus in your blood, specifically at least 1,000 copies per milliliter, as measured during the screening process.
  • Must not have taken any medicine for HIV before joining the study. This means you are antiretroviral-naïve, which means you haven't had any treatment for HIV since being diagnosed.
  • Must be able to understand and sign a form that explains the study and agree to follow the study's rules. This is called giving informed consent.
  • If you are joining the study in France, you must be part of a social security system or have benefits from it.

Who cannot join the trial?

7 criteria

  • Individuals who have previously received treatment for their HIV-1 infection cannot participate. This means if you have taken any medication to treat HIV before, you are not eligible.
  • Participants who are not adults are excluded. Only adults can join the study.
  • People who are not able to follow the study procedures or attend the required visits are not eligible.
  • Individuals with other significant health issues that might interfere with the study are excluded. This means if you have other serious medical conditions, you may not be able to participate.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Participants who are part of another clinical trial at the same time are not eligible.
  • Individuals with a history of allergic reactions to the study medications are excluded. This means if you have had allergies to similar drugs, you cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Dolutegravir/Lamivudine

    is a combination of two medications used as a first-line treatment for adults who are new to antiretroviral therapy. This combination helps to reduce the amount of HIV in the blood, which is known as viral suppression. It is taken orally once a day.

  • Cabotegravir

    is a long-acting medication used in combination with another drug to maintain viral suppression in people with HIV. It is given as an injection every two months after the initial treatment phase with oral medications.

  • Rilpivirine

    is another long-acting medication that is used together with cabotegravir to help keep the HIV virus suppressed in the body. Like cabotegravir, it is administered as an injection every two months.

What is already known about the treatment

  • Dolutegravir/Lamivudine

    This medication is administered orally as a once-daily tablet. It is currently used in medicine as a first-line treatment for HIV-1 infection, particularly in individuals who have not previously received antiretroviral therapy. The main therapeutic indication is to suppress the HIV virus in the blood. At the molecular level, dolutegravir inhibits the integrase enzyme, preventing the integration of viral DNA into the host cell genome, while lamivudine inhibits reverse transcriptase, blocking the conversion of viral RNA into DNA. This combination is classified as an antiretroviral therapy.

  • Cabotegravir/Rilpivirine

    This medication is administered as a long-acting intramuscular injection every two months. It is currently being studied for its effectiveness in maintaining virologic suppression in adults with HIV-1 infection who have achieved initial suppression with oral dolutegravir/lamivudine. The main therapeutic indication is to maintain low levels of the HIV virus in the blood. Cabotegravir works by inhibiting the integrase enzyme, similar to dolutegravir, while rilpivirine is a non-nucleoside reverse transcriptase inhibitor that prevents the virus from replicating. This combination is classified as a long-acting antiretroviral therapy.

Investigated diseases

HIV-1 Infection – HIV-1 infection is a chronic viral condition caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4+ T cells. As the virus replicates, it gradually weakens the immune system, making the body more susceptible to infections and certain cancers. The progression of the disease can vary, but without intervention, it can lead to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. During the early stages, individuals may experience flu-like symptoms, but as the infection progresses, symptoms may become more severe and persistent. The virus is primarily transmitted through unprotected sexual contact, sharing needles, or from mother to child during childbirth or breastfeeding. Regular monitoring of viral load and CD4+ cell count is crucial in managing the disease and preventing progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503893-19-00Protocol code219700Estimated enrolment232 patientsSponsorViiv Healthcare UK Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.