Study on the Effects of GSK3739937 for Adults with HIV-1 Who Have Not Yet Received Treatment

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 medication known by its code name, GSK3739937. The purpose of the study is to evaluate how well this medication 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 patients.

Participants in the study will be randomly assigned to receive either the GSK3739937 tablets or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a short period, during which participants will take the assigned tablets once a day for seven days. Throughout the study, participants will be closely monitored to observe any changes in their health and to measure the levels of the virus in their blood.

The study aims to provide valuable information about the potential of GSK3739937 as a treatment option for individuals who have not yet received any antiretroviral therapy for their HIV-1 infection. This research is an important step in developing new treatments that could improve the lives of people living with HIV-1.

1 joining the study

Upon joining the study, participants are required to meet specific criteria, including being between 18 to 65 years old, having a confirmed HIV infection, and being treatment-naive, meaning no prior antiretroviral therapy has been received.

Participants must have a CD4+ T-cell count of at least 200 cells/mm3 and a plasma HIV-1 RNA level between 3,000 and 1,000,000 copies/mL.

2 initial assessment

An initial assessment is conducted to confirm eligibility and health status, excluding the presence of any conditions that might interfere with the study.

3 treatment phase

Participants begin a 7-day treatment phase with the study medication, VH3739937, administered orally in tablet form.

The dosage is once daily, and the medication is designed to evaluate its antiviral activity in treatment-naive adults living with HIV-1.

4 monitoring and evaluation

Throughout the treatment phase, participants are monitored for changes in plasma HIV-1 RNA levels, with the primary goal being the maximum change from baseline through Day 8.

Secondary evaluations include monitoring for any serious adverse events, deaths, or adverse events leading to discontinuation.

5 post-treatment assessment

On Study Day 8, participants are expected to start a commercially available standard of care antiretroviral treatment regimen.

Further assessments may be conducted to evaluate the pharmacokinetics of VH3739937, which involves understanding how the drug is absorbed, distributed, metabolized, and excreted in the body.

Who Can Join the Study?

Participants must be between 18 and 65 years old at the time of signing the consent form.
Participants must be willing and able to start a standard HIV treatment on the 8th day of the study.
Participants should be generally healthy, except for having HIV.
Participants need to have a CD4+ T-cell count of at least 200 cells per cubic millimeter. CD4+ T-cells are a type of white blood cell important for the immune system.
Participants must have documented HIV infection with a plasma HIV-1 RNA level between 3,000 and 1,000,000 copies per milliliter. This measures the amount of HIV in the blood.
Participants must have a positive HIV antibody test, which confirms HIV infection.
Participants should be treatment naive, meaning they have not received any HIV treatments since being diagnosed.
Men must weigh at least 50 kg (110 lbs), and women must weigh at least 45 kg (99 lbs). All participants should have a BMI (Body Mass Index) between 18.5 and 35.0 kg/m². BMI is a measure of body fat based on height and weight.
Participants who were considered female at birth must not be able to have children.
Participants must be able to understand and sign the consent form, agreeing to participate in the study.

Who Cannot Join the Study?

Individuals who are currently receiving treatment for HIV. This study is for those who have not started any treatment yet.
People who have other serious health conditions that might interfere with the study. This means if you have another illness that could affect the results, you might not be able to join.
Participants who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Individuals who have participated in another clinical trial recently. This is to avoid any interference from other treatments or medications.
People who have allergies or reactions to the study medication or similar drugs. This is to prevent any harmful side effects.
Anyone who is unable to follow the study procedures or attend the required visits. This is important to ensure accurate results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Hospital Universitario Araba	Vitoria	Spain
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Evangelismos S.A.	Athens	Greece
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie	Szczecin	Poland
Wojewodzki Szpital Zakazny W Warszawie SPZOZ	Warsaw	Poland
Hijgrroe Uqlcktgqwyeke Dn Lt Psmzjrvf	Madrid	Spain
Hnvugbty Uizolfzcwhurn dv A Cdgknd	A Coruna Galicia	Spain
Uuuuwrrcfe Gvyvllx Huqiemod Afdjeee	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	11.12.2023
Italy	Not recruiting	11.12.2023
Poland	Not recruiting	11.12.2023
Spain	Not recruiting	11.12.2023

Trial locations

Investigated drugs:

Gsk3739937

VH3739937 is an experimental medication being studied for its potential to reduce the amount of HIV-1 virus in the body. It is being tested in people who have not received any previous treatment for HIV-1. The study aims to understand how well this medication can lower the virus levels, how safe it is for patients, and how the body processes it over a period of 7 days when used alone.

Investigated diseases:

HIV infection

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 intervention, 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:

2023-505780-37-00

Protocol code:

212580

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects of GSK3739937 for Adults with HIV-1 Who Have Not Yet Received Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?