Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide for HIV Patients with Good Control and Neuropsychiatric Concerns

Fast replyRegistered drug
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 effects of switching medications in people living with HIV who have good control of the virus and experience certain mental health challenges, such as anxiety or depression. The study involves two treatments: one group will continue their current medication, which includes Dolutegravir and Lamivudine (known as DTG/3TC), while the other group will switch to a new combination of medications called Bictegravir, Emtricitabine, and Tenofovir Alafenamide (known as BIC/FTC/TAF). The purpose of the study is to evaluate the safety and appropriateness of switching to the new medication combination.

Participants in the study will be randomly assigned to either continue with their current treatment or switch to the new medication. The study will be conducted over a period of time, during which participants will take their assigned medication daily in the form of film-coated tablets. The study aims to monitor and compare any side effects, particularly those affecting mental health, that may occur in both groups. The trial will also assess if there are any reasons for participants to stop their treatment due to these side effects.

The study is designed to ensure that participants are closely monitored for any changes in their health, especially regarding neuropsychiatric effects, which relate to both the nervous system and mental health. The trial will help determine if switching to the new medication is a safe and effective option for people with HIV who are managing their condition well but have vulnerabilities related to mental health.

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 participant will be assessed to ensure they meet the inclusion criteria. This includes being over 18 years old, having a diagnosis of HIV, and currently receiving treatment with Dolutegravir/Lamivudine (DTG/3TC).

    The participant's HIV viral load must be less than 50 copies/mL, confirmed within 14 days prior to the screening visit.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's current health status and any existing neuropsychiatric conditions such as insomnia, anxiety disorders, or depressive disorders.

  3. Step 3

    Randomization

    Participants will be randomly assigned to either continue their current treatment with DTG/3TC or switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF).

    Both treatments are administered orally in the form of film-coated tablets.

  4. Step 4

    Treatment phase

    Participants will take their assigned medication daily. The dosage for BIC/FTC/TAF is 50 mg/200 mg/25 mg, and for DTG/3TC it is 50 mg/300 mg.

    The treatment phase will continue until the estimated end date of the trial, which is May 2, 2024.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, participants will be monitored for any adverse effects, particularly neuropsychiatric effects graded 2-4 according to the AIDS Clinical Trials Group Adverse Events Grading Score.

    Regular follow-up visits will be scheduled to assess the participant's health and the effectiveness of the treatment.

  6. Step 6

    Completion of the trial

    Upon completion of the trial, participants will undergo a final assessment to evaluate the overall safety and appropriateness of the treatment they received.

    The results will contribute to understanding the safety of switching from DTG/3TC to BIC/FTC/TAF in individuals with good virological control and neuropsychiatric vulnerabilities.

Who can join the trial?

4 criteria

  • Must be an adult over 18 years old who has been diagnosed with HIV using standard medical tests.
  • Currently receiving a specific type of HIV treatment called DTG/3TC.
  • The most recent test for the amount of HIV in the blood, done within the last 6 months, must show less than 50 copies per milliliter. If this test wasn't done in the last 14 days, it needs to be confirmed during the screening visit that the amount is less than 50 copies per milliliter.
  • Must have been diagnosed by a qualified doctor with any of the following conditions: Insomnia (trouble sleeping), Anxiety disorders (feeling very worried or nervous), or Depressive disorders (feeling very sad or hopeless).

Who cannot join the trial?

4 criteria

  • Individuals who do not have HIV cannot participate. HIV is a virus that affects the immune system.
  • Participants must be within a specific age range, which is not specified here.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Vulnerable populations, such as those who might not be able to give informed consent, are not included in this study.
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

  • DTG/3TC

    is a combination medication used to treat HIV. It includes two active ingredients that work together to help control the virus in the body. This medication is typically used by people who have already achieved good control over their HIV infection and are looking to maintain that control.

  • BIC/FTC/TAF

    is another combination medication used for the treatment of HIV. It contains three active ingredients that help to suppress the virus, making it a comprehensive option for managing HIV. This medication is often considered for patients who are switching from another HIV treatment to ensure continued control of the virus.

What is already known about the treatment

  • Dolutegravir/Lamivudine (DTG/3TC)

    This medication is administered orally in tablet form and is currently used in the treatment of HIV. It is well-documented in medical literature as a combination therapy for managing HIV infection. The main therapeutic indication is to maintain viral suppression in individuals with HIV. At the molecular level, Dolutegravir inhibits the integrase enzyme, preventing the integration of viral DNA into the host genome, while Lamivudine inhibits reverse transcriptase, blocking viral replication. It is classified as an antiretroviral medication.

  • Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

    This medication is also administered orally in tablet form and is used in the treatment of HIV. It is recognized in medical literature as a combination therapy for HIV management. The primary therapeutic indication is to maintain viral suppression in individuals with HIV. Bictegravir inhibits the integrase enzyme, Emtricitabine inhibits reverse transcriptase, and Tenofovir Alafenamide is a prodrug that also inhibits reverse transcriptase, all working together to prevent viral replication. 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 disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. In the early stages, many people experience flu-like symptoms, but as the virus progresses, it can lead to more severe health issues. Without treatment, HIV can advance to Acquired Immunodeficiency Syndrome (AIDS), where the immune system is severely damaged. The progression of the disease varies among individuals, and some may remain asymptomatic for years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511951-16-00Protocol codeGESIDA 11920Estimated enrolment84 patientsSponsorFundacion Seimc Gesida

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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).