Recruiting

Study on Venetoclax for Reducing HIV Reservoir in Patients on Antiretroviral Therapy

Verified siteRegistered drugNo placebo

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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 HIV-1 disease and involves the use of a treatment called venetoclax, which is also known by its code names ABT-199 and GDC-0199. The purpose of the study is to determine the safety of venetoclax in people living with HIV who are already on antiretroviral therapy. Venetoclax is a medication that helps promote the natural process of cell death, known as apoptosis, in HIV-infected cells, with the aim of reducing the size of the HIV reservoir in the body.

Participants in the study will receive venetoclax in the form of film-coated tablets, taken orally. The study will be conducted in phases, starting with a smaller group of participants to assess safety, and then expanding to include more participants. Throughout the study, participants will continue their regular antiretroviral therapy while being monitored for any side effects or changes in their health. The study is expected to run until 2027, with recruitment starting in 2024.

The trial is designed to ensure that any treatment-related adverse events are carefully recorded and assessed. This will help researchers understand the safety profile of venetoclax when used alongside standard HIV treatments. The ultimate goal is to explore whether venetoclax can be a safe and effective addition to current HIV therapies, potentially offering a new approach to managing the disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the study's purpose, procedures, and potential risks and benefits.
You will need to confirm your eligibility, which includes having a documented HIV-1 infection and meeting other specific health criteria.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status. This includes confirming that you have been on a stable antiretroviral therapy (ART) regimen for at least two years.
Your HIV-1 plasma RNA levels and CD4+ T cell count will be checked to ensure they meet the study requirements.
Step 3
Medication administration
You will begin taking the study medication, venetoclax, which is provided as a 100 mg film-coated tablet for oral use.
The dosage, frequency, and duration of administration will be explained to you by the study team. It is important to follow the instructions carefully.
Step 4
Ongoing monitoring
Throughout the study, your health will be monitored regularly to assess the safety of venetoclax. This includes checking for any side effects or adverse events.
You will continue your regular ART regimen during the study.
Step 5
Completion of study
At the end of the study period, a final assessment will be conducted to evaluate the effects of the medication on your health.
You will be informed about the study's findings and any next steps regarding your treatment.

Who can join the trial?

10 criteria

Must have a documented HIV-1 infection.
If male and sexually active with women, must use an effective method of contraception (birth control) or have a partner who uses one, from the day before the first dose and for at least 2 weeks after stopping the study drug.
Must be between 18 and 65 years old, including both ages.
Must have been receiving combination ART (antiretroviral therapy) for at least 2 years and on the same ART regimen for at least 4 weeks before the screening visit.
Must have HIV-1 plasma RNA (a measure of the virus in the blood) less than 50 copies/mL for more than 2 years and less than 20 copies/mL at screening. A single episode of 50-500 copies/mL is allowed if the next test was less than 50 copies/mL.
Must have a CD4+ T cell count (a type of white blood cell) greater than 500 cells/µL at screening and at least two counts greater than 500 cells/µL in the 24 months before screening.
Must be able and willing to provide informed consent and continue ART throughout the study.
If planning to receive a SARS-CoV-2 vaccine (COVID-19 vaccine) during the study, enrollment and starting the study therapy will be delayed until 4 weeks after completing the vaccination. Screening can start before or during vaccination.
If female, must either be of non-child-bearing potential (cannot become pregnant) or, if of child-bearing potential, have a negative pregnancy test at both screening and Day 1 and agree to use specified methods of contraception to avoid pregnancy.
All participants must agree not to participate in any conception process (trying to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) during the study.

Who cannot join the trial?

4 criteria

Patients who do not have HIV-1 disease cannot participate.
Patients who are not on ART (antiretroviral therapy) cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Verified sites

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Aarhus University Hospital
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Aarhus, Denmark

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Investigated drugs

Venetoclax is a medication used in this clinical trial to help reduce the number of HIV-infected cells in the body. It works by promoting a process called apoptosis, which is a natural way for the body to get rid of damaged or unwanted cells. In this study, venetoclax is being tested to see if it can help decrease the size of the HIV reservoir in people living with HIV who are already on antiretroviral therapy. The main goal is to determine if venetoclax is safe for these patients to use.

Venetoclax

What is already known about the treatment

Venetoclax – Venetoclax is taken orally in the form of tablets and is currently being studied in clinical trials for its potential use in treating HIV-1 disease. It is primarily known for its role in cancer treatment, but researchers are exploring its ability to help reduce the size of the HIV reservoir in people living with HIV who are already on antiretroviral therapy. Venetoclax works by blocking a protein called BCL-2, which helps infected cells survive; by inhibiting this protein, venetoclax promotes the death of these cells. It is classified as a BCL-2 inhibitor in pharmacology.

Investigated diseases

HIV-1 disease – HIV-1 disease is caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4+ T cells. As the virus replicates, it gradually depletes these cells, weakening the body's ability to fight infections and diseases. Initially, individuals may experience flu-like symptoms, but as the disease progresses, it can lead to more severe immune system damage. Over time, the reduction in CD4+ T cells can result in increased susceptibility to opportunistic infections and certain cancers. The progression of the disease varies among individuals, with some experiencing rapid decline in immune function, while others may remain asymptomatic for years. The disease is primarily transmitted through contact with infected bodily fluids, such as blood, semen, vaginal fluids, and breast milk.