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Study on Switching HIV Treatment to Dolutegravir/Lamivudine in Patients Aged 50+ with Virologic Suppression

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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 Human Immunodeficiency Virus (HIV) in individuals who are at least 50 years old and have their virus levels under control. The study involves switching from one medication to another. Participants will switch from taking a single tablet regimen called Biktarvy, which contains the active substances emtricitabine, tenofovir alafenamide, and bictegravir, to another single tablet regimen called Dovato, which contains lamivudine and dolutegravir sodium. The purpose of the study is to evaluate how well the new regimen maintains control of the virus.

The study will last for a total of 96 weeks, with participants taking the new medication once daily. During this time, the safety and tolerability of the new treatment will be monitored. Participants will have regular check-ups to ensure that the virus remains suppressed and to observe any changes in their health. The study will also look at the occurrence of any side effects or adverse reactions to the new medication.

Participants will be closely monitored for any signs of the virus becoming resistant to the new treatment. The study aims to provide valuable information on the effectiveness of switching medications in older adults living with HIV, ensuring that their treatment remains effective and safe over time.

The research process

The trial runs in 4 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, participants will begin by taking a single tablet regimen of Biktarvy, which contains emtricitabine, tenofovir alafenamide, and bictegravir. This medication is taken orally once daily.

    Participants must have been on this regimen for at least 6 months prior to the start of the study.

  2. Step 2

    Switching medication

    After the initial phase, participants will switch to a new medication called Dovato, which contains lamivudine and dolutegravir sodium. This is also a single tablet taken orally once daily.

    The switch is designed to evaluate the maintenance of viral suppression with the new medication.

  3. Step 3

    Monitoring and evaluation

    Participants will be monitored at various intervals to assess the effectiveness and safety of the new medication. Key time points include 24, 48, and 96 weeks after the switch.

    The primary goal is to ensure that the viral load remains below 50 copies/mL at Week 48. Secondary evaluations will include viral load assessments at Weeks 24 and 96, as well as changes in immune cell counts.

  4. Step 4

    Completion of the study

    The study is expected to conclude by January 31, 2026. Participants will have completed all required assessments and monitoring by this time.

    Final evaluations will include a review of any adverse reactions and overall health outcomes related to the medication switch.

Who can join the trial?

11 criteria

  • Must be at least 50 years old at the time of giving consent.
  • Must sign a written consent form before any study-related activities begin.
  • If participating in France, must be part of a social security system.
  • Can be male or female. If female, must not be pregnant or breastfeeding, confirmed by specific tests.
  • Must be living with HIV-1 and have a documented low level of the virus in the blood (less than 50 copies per milliliter) within 3 months before the study starts.
  • Must have been on continuous antiretroviral therapy (ART) for at least 1 year, with short breaks allowed for safety reasons.
  • Must have been on a specific combination of medications (BIC/FTC/TAF) for at least 6 months before the study starts.
  • Must have a low level of the virus in the blood (less than 50 copies per milliliter) at the start of the study.
  • Must not have changed treatment due to a confirmed increase in the virus level (200 copies per milliliter or more).
  • If the full treatment history is unknown for more than 5 years, eligibility can be discussed with a medical expert.
  • Must be able to provide written consent.

Who cannot join the trial?

6 criteria

  • Individuals who do not have HIV (Human Immunodeficiency Virus) cannot participate. This is a virus that attacks the body's immune system.
  • Participants must be able to maintain virologic suppression. This means the virus is controlled and not actively multiplying in the body.
  • Participants must be switching from a specific medication combination called BIC/FTC/TAF to another called DTG/3TC. These are different types of HIV medications.
  • Participants must be within certain age ranges, which are not specified here.
  • Both male and female participants are eligible, but certain conditions may apply.
  • Participants from vulnerable populations may be included, but specific criteria are not detailed here.
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Investigated drugs

  • DTG/3TC

    is a single tablet regimen used in this study. It combines two medications, dolutegravir and lamivudine, into one pill. This combination is used to maintain control of HIV in people who have already achieved viral suppression, meaning the virus is at very low levels in their body. The study is testing how well this combination works when patients switch from another HIV treatment.

  • BIC/FTC/TAF

    is another single tablet regimen that combines three medications: bictegravir, emtricitabine, and tenofovir alafenamide. This combination is used to control HIV by keeping the virus at low levels in the body. In this study, patients who are already taking this combination and have their virus under control are switching to the DTG/3TC regimen to see if they can maintain their viral suppression.

What is already known about the treatment

Dolutegravir/Lamivudine (DTG/3TC) – This medication is administered orally as a single tablet taken once daily. It is currently being studied in clinical trials for its effectiveness in maintaining viral suppression in people living with HIV who are at least 50 years old and are already virologically suppressed. The main therapeutic indication is for the treatment of HIV infection. At the molecular level, Dolutegravir works by inhibiting the integrase enzyme, preventing the virus from integrating its genetic material into the host cell's DNA, while Lamivudine inhibits reverse transcriptase, blocking the conversion of viral RNA into DNA. This combination 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 (T cells), which are crucial for fighting infections. Over time, HIV can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. As the virus progresses, it can lead to acquired immunodeficiency syndrome (AIDS), the most severe phase of HIV infection. During this stage, the immune system is badly damaged, and the body becomes vulnerable to opportunistic infections and certain cancers. Without treatment, HIV can gradually weaken the immune system, but with proper management, individuals can maintain a healthy life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-503137-66-00Protocol code219516Estimated enrolment235 patientsSponsorViiv Healthcare UK Limited

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).