A study testing VH4524184 with emtricitabine and tenofovir alafenamide compared to dolutegravir and lamivudine in adults with HIV-1 who have not received treatment before
This study involves people living with HIV-1 infection who have not received treatment before. The study will compare different treatment approaches. Some people will receive tablets containing an investigational medicine called VH4524184 (also known as GSK4524184) together with a combination of two approved medicines, emtricitabine and tenofovir alafenamide, which are given as a single tablet called Descovy. Other people will receive a different approved combination treatment called Dovato, which contains lamivudine and dolutegravir sodium. All medicines in this study are taken by mouth. These medicines belong to a group called antiretroviral treatments, which work to control the virus in the body.
The purpose of this study is to find out how well the investigational treatment containing VH4524184 works in reducing the amount of virus in the blood compared to the approved treatment, and to check how safe these treatments are. The study will look at whether the amount of virus in the blood drops to very low levels and stays low during the treatment period. The study will also measure changes in certain blood cells that are important for the immune system and will check for any side effects that may occur during treatment.
People who join this study will be assigned to receive one of the treatment combinations and will take their assigned medicine for up to 24 months. During this time, they will have regular visits where blood samples will be collected to measure the amount of virus in the blood and to check their overall health. The study will monitor how well the treatment works and how people respond to it over time. The study is expected to start in early 2026 and continue until late 2028.
1Initial treatment assignment
On the first day of the study, treatment will be assigned. The study medication will be administered orally.
Treatment will consist of either VH4524184 combined with emtricitabine and tenofovir alafenamide (one treatment option), or dolutegravir and lamivudine (control treatment option).
All medications are taken by mouth in tablet form.
2Daily medication intake during treatment period
The assigned medication regimen will be taken daily throughout the treatment period.
If assigned to VH4524184 with emtricitabine and tenofovir alafenamide, this combination will be taken as film-coated tablets by mouth.
If assigned to the control treatment, Dovato (containing 50 mg lamivudine and 300 mg dolutegravir) will be taken as film-coated tablets by mouth.
The alternative control option is Descovy (containing 200 mg emtricitabine and 25 mg tenofovir alafenamide) taken as film-coated tablets by mouth.
3Assessment at month 12
At month 12, the primary assessment will be conducted to measure the amount of HIV-1 virus in the blood.
The goal is to determine if the virus level has decreased to less than 50 copies per milliliter of blood plasma.
Blood samples will be collected to measure CD4+ T-cell count, which indicates how well the immune system is functioning.
4Continued treatment and monitoring until month 24
Treatment will continue with daily medication intake until month 24.
Regular assessments will be performed to monitor the virus level in the blood, with the target of maintaining levels below 50 copies per milliliter.
Blood tests will be conducted periodically to track changes in CD4+ T-cell count from the initial baseline measurement.
Safety monitoring will occur throughout this period to assess how well the medication is tolerated and to identify any side effects.
5Final assessment at month 24
At month 24, final assessments will be completed.
Blood samples will be analyzed to confirm virus levels remain below 50 copies per milliliter.
The final measurement of CD4+ T-cell count will be taken and compared to the baseline value to evaluate immune system improvement.
A comprehensive safety evaluation will be conducted to review the overall tolerability of the treatment regimen throughout the study period.
Who Can Join the Study?
Requirements to participate in this study:
You must be at least 18 years old when you sign the consent form
Your CD4+ T-cell count (a type of white blood cell that helps fight infections) must be 200 cells per microliter or higher at the screening visit
You must have confirmed HIV-1 infection (a specific type of HIV virus) and your plasma HIV-1 RNA (the amount of virus in your blood) must be 1000 copies per milliliter or higher at screening
You must be treatment-naïve, which means you have never taken HIV medicines after being diagnosed with HIV-1 infection. If you previously used HIV prevention medicines taken by mouth before or after possible exposure to HIV, you can still participate. However, if you previously used long-acting injectable cabotegravir, you cannot participate
If you are enrolling in France, you must be part of or benefit from the social security system
Your body weight must be at least 50.0 kilograms (110 pounds) if you were assigned male at birth, or at least 45.0 kilograms (99 pounds) if you were assigned female at birth. Your BMI (body mass index, which is a measure of body fat based on height and weight) must be between 18.5 and 35.5
If you were assigned male at birth, there are no birth control requirements for you
If you were assigned female at birth, you must not be pregnant or breastfeeding. You must either be unable to become pregnant, or you must use a highly effective birth control method (with less than 1% failure rate) before the study, during the study, and for at least 1 week after the last dose of the study medicine. You must have a negative pregnancy test at screening and on the first day of treatment
You must be able to sign the consent form and follow all study requirements and restrictions
Who Cannot Join the Study?
The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this trial
Typically, exclusion criteria may include things like certain other health conditions, medications you are taking, pregnancy status, or previous treatments, but these specific details are not available in the provided information
VH4524184 is an investigational medication being studied as a treatment for HIV-1 infection. It is taken by mouth and is being tested in combination with other HIV medications to see if it can effectively reduce the amount of virus in the blood of people who have not received HIV treatment before.
Emtricitabine is an antiviral medication used to treat HIV infection. It works by blocking an enzyme that the virus needs to multiply, helping to reduce the amount of HIV in the body and improve the immune system.
Tenofovir Alafenamide is an antiviral medication used to treat HIV infection. It works by interfering with the virus’s ability to reproduce, which helps control the infection and allows the immune system to work better.
Dolutegravir is an antiviral medication used to treat HIV infection. It belongs to a class of drugs called integrase inhibitors, which prevent the virus from inserting its genetic material into human cells, thereby stopping the virus from multiplying.
Lamivudine is an antiviral medication used to treat HIV infection. It helps prevent the virus from multiplying in the body, which reduces the viral load and helps protect the immune system.
HIV Infections – HIV Infections are caused by the Human Immunodeficiency Virus, which attacks the body’s immune system. The virus specifically targets cells that help the body fight off infections and diseases. When HIV enters the body, it begins to multiply and gradually weakens the immune system over time. As the infection progresses, the body becomes less able to defend itself against various illnesses. Without proper management, the number of immune cells decreases significantly. The virus spreads through contact with certain body fluids from an infected person.
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