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Study Comparing DTG/3TC and BIC/FTC/TAF for Maintaining HIV Control in Adults

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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, a virus that attacks the body's immune system. The study involves two different treatments. The first treatment is a medication called Dovato, which contains the active substances lamivudine and dolutegravir sodium. The second treatment is a medication called Biktarvy, which includes the active substances emtricitabine, tenofovir alafenamide, and bictegravir (also known by the code name GS-9883). Both medications are taken as film-coated tablets.

The purpose of this study is to compare the effectiveness of these two treatments in maintaining control over the virus in people living with HIV. Participants in the study will be randomly assigned to receive either Dovato or Biktarvy. The study will last for a period of up to 96 weeks, during which participants will take their assigned medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the level of the virus in their blood.

This trial aims to determine if Dovato is as effective as Biktarvy in keeping the virus under control. Participants will be closely monitored to ensure their safety and to gather information on how well each treatment works. The study is designed to provide valuable insights into the management of HIV, potentially leading to improved treatment options for those living with the virus.

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, the participant must provide written informed consent after understanding the study information.

    Eligibility is confirmed by meeting criteria such as being 18 years or older, having a confirmed HIV infection, and maintaining HIV RNA levels below 50 copies/mL for at least 24 weeks before screening.

  2. Step 2

    Initial assessment

    An initial medical evaluation is conducted, including a review of medical history, laboratory tests, and cardiac monitoring to ensure clinical stability.

    Females of childbearing potential must use effective contraception and undergo urine pregnancy testing at specified times.

  3. Step 3

    Randomization and treatment

    Participants are randomly assigned to one of two treatment groups: DTG/3TC or BIC/FTC/TAF.

    DTG/3TC group receives Dovato 50 mg/300 mg film-coated tablets, taken orally.

    BIC/FTC/TAF group receives Biktarvy 50 mg/200 mg/25 mg film-coated tablets, taken orally.

  4. Step 4

    Treatment duration

    The treatment is administered continuously until the estimated end date of the trial on January 1, 2025.

    Participants are monitored for the maintenance of virological suppression throughout the study.

  5. Step 5

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the participant's health and the effectiveness of the treatment.

    The primary endpoint is the proportion of patients with plasma HIV-1 RNA levels of 50 copies/mL or higher.

Who can join the trial?

9 criteria

  • Understand the study information provided and be capable of giving written informed consent.
  • Have a confirmed **HIV** infection.
  • Be **18 years of age or older** on the day of screening.
  • Have **HIV RNA** (a measure of the virus in the blood) less than 50 copies/mL for at least 24 weeks before screening.
  • Be receiving any treatment for HIV that includes more than one pill a day or a single tablet that contains certain medications like cobicistat-boosting, efavirenz, or tenofovir disoproxyl fumarate, for at least 24 weeks before screening. There are specific conditions for those taking TAF (a type of medication).
  • Have no evidence of previous **viral failure** (when the virus is not controlled by treatment).
  • Have no known or suspected **resistance** to the study drugs (when the virus does not respond to the medication).
  • If female and able to have children, must use highly effective methods of **contraception** from study inclusion and for at least 4 weeks after the last study visit. All female volunteers must agree to undergo urine pregnancy testing at specified times.
  • Be in **clinical stability**, meaning participants should be healthy (other than having HIV) as determined by a medical evaluation, which includes medical history, laboratory tests, and heart monitoring.

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 adults, meaning they should be of a certain age, typically 18 years or older.
  • Both men and women can participate, but they must meet all other criteria.
  • Individuals who are part of a vulnerable population, such as those who may not be able to give informed consent, are not eligible.
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Investigated drugs

  • DTG/3TC

    is a combination of two medications used to maintain control of HIV in people who are already virologically suppressed. It helps keep the virus at low levels in the body, preventing it from multiplying and causing harm.

  • BIC/FTC/TAF

    is another combination of three medications used for the same purpose of maintaining control of HIV in people who are already virologically suppressed. This combination also works to keep the virus at low levels, helping to prevent the progression of the disease.

What is already known about the treatment

  • Dolutegravir/Lamivudine (DTG/3TC)

    This medication is administered orally in tablet form and is currently being studied for its effectiveness in maintaining viral suppression in individuals with HIV. It is well-documented in medical literature as a combination therapy for HIV treatment. The main therapeutic indication is for the maintenance of virological suppression in adults 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 being evaluated for its role in maintaining viral suppression in people living with HIV. It is recognized in medical literature as a combination therapy for HIV. The primary therapeutic use is to maintain virological suppression in adults with HIV. Bictegravir works by inhibiting the integrase enzyme, Emtricitabine inhibits reverse transcriptase, and Tenofovir Alafenamide is a prodrug of tenofovir, which also inhibits reverse transcriptase, all contributing to the prevention of viral replication. It is classified as an antiretroviral medication.

Investigated diseases

Human Immunodeficiency Virus (HIV) Infection – 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. In the early stages, many people experience flu-like symptoms, but as the infection 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. However, with proper medical care, HIV can be controlled, and individuals can live long, healthy lives.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515167-56-00Protocol codeGESIDA 11720Estimated enrolment555 patientsSponsorFundacion Seimc Gesida

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.

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