#1 Clinical Trials Search in Europe

Study on the Effects of VH4524184 for Adults Newly Diagnosed with HIV

2 1

What is this study about?

This clinical trial is focused on studying the effects of a new treatment for people living with HIV-1, a virus that attacks the immune system. The treatment being tested is a tablet containing the active substance VH4524184, which is being developed by VIIV Healthcare Limited. The purpose of the study is to evaluate how well this new treatment works in reducing the amount of the virus in the body, as well as to assess its safety and how well it is tolerated by participants.

Participants in the study will be adults who have not received any previous treatment for their HIV-1 infection. The study will last for 10 days, during which participants will take the VH4524184 tablet as a monotherapy, meaning it will be the only treatment they receive for their HIV-1. Some participants will receive a placebo, which is a tablet that looks like the treatment but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, although the sponsor will be aware.

Throughout the study, researchers will monitor the participants’ health and the levels of HIV-1 in their blood. They will also keep track of any side effects or adverse events that occur. The study aims to provide valuable information about the potential of VH4524184 as a new treatment option for people living with HIV-1, helping to improve future treatment strategies for this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and HIV infection status.

A negative pregnancy test is required for participants of childbearing potential before starting the study.

2 initial assessment

An initial medical evaluation is conducted, including a review of medical history, physical examination, and laboratory tests.

Baseline measurements for HIV-1 RNA levels and CD4+ T-cell counts are recorded.

3 medication administration

The study involves taking a medication called VH4524184 in the form of a tablet.

The medication is taken orally once daily for a duration of 10 days.

4 monitoring and follow-up

Participants are monitored for any adverse events or side effects throughout the study.

Regular blood tests are conducted to measure changes in HIV-1 RNA levels and CD4+ T-cell counts.

5 completion of study medication

After 10 days of taking the study medication, participants stop the medication.

A final assessment is conducted to evaluate the effects of the medication on HIV-1 RNA levels and overall health.

6 transition to standard care

Participants begin standard-of-care antiretroviral therapy (ART) as determined with the investigator.

Ongoing health monitoring continues as part of standard HIV care.

Who Can Join the Study?

  • Participant must be between 18 and 65 years old at the time of signing the consent form.
  • If a urine pregnancy test is unclear, a blood test is needed. If the blood test shows pregnancy, the participant cannot join the study.
  • The study doctor will check medical history, menstrual history, and recent sexual activity to ensure a female participant is not in early pregnancy.
  • Participant must be able to give signed consent to join the study.
  • Participant must be willing and able to start standard HIV treatment on the 10th day of the study.
  • Participants should be generally healthy, except for having HIV, as determined by the study doctor through medical history, physical exam, lab tests, and heart monitoring.
  • Participant must have a positive test for HIV antibodies, which shows HIV infection.
  • Participant must have documented HIV infection and a certain level of HIV in the blood (at least 3,000 copies/mL). This test can be repeated once during the screening period if needed.
  • Participant must have a CD4+ T-cell count of at least 200 cells/mm3. CD4+ T-cells are a type of white blood cell important for the immune system.
  • Participant must be treatment-naïve, meaning they have not received any HIV medication after being diagnosed with HIV-1.
  • Participant must not have used any specific HIV prevention medications, like INSTI, before.
  • Participant must weigh at least 50 kg (110 lbs) for men and 45 kg (99 lbs) for women, and have a Body Mass Index (BMI) between 18.5 and 31.0 kg/m2.
  • A participant who can have children must have a negative blood pregnancy test at screening and a negative urine pregnancy test on the first day of the study before taking the study medication.

Who Cannot Join the Study?

  • Individuals who have previously been treated for HIV cannot participate. This means if you have taken any medication for HIV before, you are not eligible.
  • Participants must not have any other serious health conditions that could interfere with the study. This means if you have another major illness, you may not be able to join.
  • Pregnant or breastfeeding women are not allowed to participate. This is to ensure the safety of both the mother and the baby.
  • Individuals who are unable to follow the study procedures or attend all required visits cannot participate. This means if you cannot commit to the study schedule, you may not be eligible.
  • Participants must not be using any other experimental drugs or treatments. This means if you are part of another clinical trial, you cannot join this one.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital Del Mar Barcelona Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Ospedaliera di Padova Padua Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hdsbilft Uiotrsofxdcbt Mscmoot Dr Vcornvmqji Santander Spain
Hoyrsxib Ds La Sglnn Cuyj I Ssnp Ptd Barcelona Spain

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
15.04.2024
Spain Spain
Not recruiting
15.04.2024

Trial locations

Investigated drugs:

VH4524184 is an investigational medication being studied for its potential to reduce the amount of HIV-1 virus in the body. This trial aims to understand how effective VH4524184 is at fighting the virus in people who have not received any previous treatment for HIV-1. The study also looks at how safe and well-tolerated the medication is, as well as how the body processes it over a period of 10 days when used alone.

Investigated diseases:

HIV Infections – HIV infection is caused by the human immunodeficiency virus, which attacks the body’s immune system, specifically the CD4 cells (T cells). 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. The progression of the disease varies among individuals, and some may remain asymptomatic for years.

Trial ID:
2023-507173-18-00
Protocol code:
218806
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study of islatravir and ulonivirine for adults with HIV who have not received previous treatment

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

  • 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

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Poland Portugal +1