A Study of Venetoclax in People with HIV-1 Infection Starting Antiretroviral Treatment to Reduce the HIV Reservoir

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What is this study about?

This study is looking at HIV-1 infection, which is a virus that attacks the immune system and can lead to serious health problems if not treated. The study will use a medication called venetoclax, which is also known by the code names ABT-199 and GDC-0199. Venetoclax works by blocking a protein called BCL-2 that helps infected cells survive. By blocking this protein, the medication may help the body eliminate cells that contain the virus. Participants in this study will take venetoclax along with standard HIV treatment, which is called antiretroviral therapy or ART. The purpose of this study is to find out if venetoclax is safe when given to people living with HIV at the time they start their HIV treatment, and to see if it can reduce the amount of HIV that remains hidden in the body, which is known as the HIV reservoir.

During the study, participants will start taking both venetoclax and ART at the same time. The study will last for about one year, during which time researchers will carefully monitor participants for any side effects or health changes. Blood samples will be collected throughout the study to measure different things, including how much HIV virus is present in the blood and how many immune cells contain the virus. The researchers will look at special types of cells called CD4+ T cells, which are important immune cells that HIV attacks. They will use several laboratory tests to count how many of these cells contain HIV genetic material, which is called HIV-DNA and HIV RNA. Some of these tests have specific names like the Intact Proviral DNA Assay or IPDA, which helps identify cells that contain complete copies of the virus that could potentially produce new virus particles.

The researchers will also track how quickly the amount of virus in the blood decreases after treatment starts, and they will examine different types of immune cells including B cells and CD8+ T cells to see how they change during treatment. Throughout the study, all health problems and side effects will be recorded and assessed to determine whether they are related to the study medication. This information will help researchers understand whether venetoclax can be safely used together with standard HIV treatment and whether it might help reduce the amount of virus that stays hidden in the body even when people are taking their regular HIV medications.

1 Starting HIV treatment and study medication

On Day 0, your HIV treatment will begin. This is the point when the study officially starts for you.

You will start taking antiretroviral therapy (HIV treatment medication) as prescribed by your doctor.

If you are assigned to the treatment group, you will also begin taking venetoclax, which is provided as 100 mg film-coated tablets taken by mouth.

The specific dosage, frequency, and duration of venetoclax administration will be determined by the study protocol and communicated to you by the study team.

2 Treatment period

You will continue taking your HIV treatment medication throughout the entire study period.

If you are taking venetoclax, you will follow the prescribed schedule for this medication.

During this period, blood samples will be collected to measure various markers, including the amount of HIV genetic material in your blood cells and the levels of different types of immune cells.

Your blood will be tested to check for CD4+ T cells (a type of immune cell affected by HIV) that contain HIV genetic material, both intact and total HIV genetic material.

Additional tests will measure HIV activity in your cells and how quickly the virus levels decrease in your blood after starting treatment.

3 Safety monitoring throughout the study

From Day 0 to Day 365, you will be monitored for any side effects or adverse events that may occur.

The study team will assess whether any side effects are related to the study medication or your HIV treatment.

Regular check-ups will be conducted to monitor your overall health and the safety of the treatment.

4 End of study at Day 365

The study will conclude at Day 365 (one year after starting).

Final blood samples will be collected to measure the frequency of immune cells containing intact HIV genetic material and other markers of HIV presence in your body.

The study team will assess changes in your immune cell counts, including B cells, CD8+ T cells, and CD4+ T cells, as well as different memory cell types.

A final safety assessment will be completed to document any adverse events experienced during the study period.

Who Can Join the Study?

You must have a documented HIV-1 infection, which is a type of virus that affects the immune system
You must agree to use condoms during all sexual intercourse until your viral load (the amount of virus in your blood) is fully suppressed to less than 50 copies per milliliter
You must be between 18 and 70 years old
Your CD4+ T cell count (a type of white blood cell that helps fight infections) must be greater than 300 cells per microliter at the beginning of the study
You must have never taken antiretroviral therapy (medicines used to treat HIV infection) before joining this study
You must be able to understand and sign the informed consent form, which explains the study details and your rights
You must be willing to continue taking antiretroviral therapy throughout the entire study
If you are a woman who cannot become pregnant, you may participate if you have gone through menopause (no periods for 12 months and at least 45 years old) or have had surgery such as removal of your uterus, fallopian tubes, or ovaries
If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study and agree to use reliable birth control methods with less than 1% failure rate, such as an intrauterine device, male partner sterilization, or other approved methods, starting 2 weeks before the study and continuing for at least 4 weeks after stopping the study medication
You must agree not to try to become pregnant or make someone pregnant, donate sperm or eggs, or participate in in vitro fertilization (a procedure to help with pregnancy) during the study
If you are a sexually active man, you must be surgically sterile or your female partner must use an effective birth control method with less than 1% failure rate from the day before the first dose until at least 4 weeks after stopping the study medication

Who Cannot Join the Study?

No exclusion criteria have been specified in the available study information

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Fgwahapfo Fcu Dl Llags Ccazkv Ej Siqz Lnz Evhercihtncw Ixkjqdigdqk Y Lg Pugibxxls Df Lb Sudzt Y Lp C	Badalona	Spain
Hsibvu Hjumukfl	Herlev	Denmark
Fuhjilavy Pdik Lj Iwbrvbbdhrxqu Bmroyqtfh Dkh Hptwylnr Utisygczijifj Lr Pmo	Madrid	Spain
Hdxddmeb Vpyo dnegkxxw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.01.2026
Spain	Recruiting	01.01.2026

Trial locations

Investigated drugs:

Venetoclax

Venetoclax is a medication that works by blocking a protein called BCL-2, which helps cells survive. In this trial, venetoclax is being tested to see if it can help destroy HIV-infected cells when given at the same time as starting HIV treatment. The goal is to reduce the number of cells in the body that contain hidden HIV virus.

ART (antiretroviral therapy) is the standard treatment for HIV infection. It is a combination of medications that work together to stop the HIV virus from multiplying in the body. In this trial, participants will be starting ART treatment, and researchers want to see if adding venetoclax at the same time can improve the results.

HIV-1 Infection – HIV-1 infection is a viral disease caused by the human immunodeficiency virus type 1, which attacks the body’s immune system. The virus primarily targets CD4+ T cells, which are white blood cells that play a crucial role in fighting infections. As the infection progresses, the number of these protective cells decreases, weakening the immune system over time. The virus integrates its genetic material into the DNA of infected cells, creating a persistent reservoir that remains in the body. Without treatment, the immune system becomes increasingly compromised, making the body vulnerable to various infections and illnesses. The progression of the disease varies among individuals, depending on factors such as viral load and immune response.

Trial ID:

2025-521841-26-00

Protocol code:

INITIATE-001

Trial Phase:

Human Pharmacology (Phase I) – Other

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A Study of Venetoclax in People with HIV-1 Infection Starting Antiretroviral Treatment to Reduce the HIV Reservoir

What is this study about?

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