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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Infanta Leonor Madrid Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Son Llatzer Palma Spain
Servei De Salut De Les Illes Balears Palma Spain
Hospital Costa del Sol Marbella Spain
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Hejonkwr Uiuquwprfpsfs dx A Cnjnae A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
27.09.2022

Trial locations

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.

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 ID:
2024-511951-16-00
Protocol code:
GESIDA 11920
NCT ID:
NCT05549180
Trial Phase:
Therapeutic confirmatory (Phase III)

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