Study on the Effectiveness of 10-1074-LS and Teropavimab in Controlling HIV in Patients with Early Stage HIV Infection

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What is this study about?

The RIO Trial is focused on studying the treatment of HIV, a virus that attacks the body’s immune system. The study is investigating the effectiveness of two specific medications, 10-1074-LS and 3BNC117-LS, which are types of proteins known as broadly neutralizing antibodies. These antibodies are designed to help control the virus in people who have been recently diagnosed with HIV and are already receiving standard treatment. The trial will compare the effects of these antibodies with a placebo to see if they can help maintain control of the virus without the need for ongoing standard treatment.

Participants in the study will receive either the antibody treatment or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study aims to observe how well the antibodies work in keeping the virus under control over a period of 20 weeks after stopping standard treatment. The trial will also monitor the safety of the treatment by checking for any side effects or adverse reactions.

Throughout the study, participants will have regular check-ups to measure their immune system’s response, including the levels of CD4 T cells, which are a type of white blood cell important for fighting infections. The study will also track how long the virus remains undetectable in the blood and how quickly it returns if it does. The goal is to understand if these antibodies can provide a new way to manage HIV without continuous medication.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, weight, and health status, such as CD4 count and HIV viral load.

Participants must have started antiretroviral therapy (ART) within six months of early HIV infection and meet other health criteria.

2 randomization

Participants are randomly assigned to one of two groups: one receiving ART plus dual long-acting HIV-specific broadly neutralizing antibodies (bNAbs), and the other receiving ART plus a placebo.

3 treatment administration

Participants receive intravenous infusions of either the bNAbs (10-1074-LS and 3BNC117-LS) or a placebo. The infusions are administered as a solution for injection.

The goal is to assess the ability of the bNAbs to maintain viral control without ART.

4 monitoring and follow-up

Participants are monitored for 20 weeks to evaluate the time to viral rebound after stopping ART.

Regular blood tests are conducted to measure CD4 T cell counts, viral load, and the presence of bNAbs in the blood.

5 safety and efficacy evaluation

Safety is assessed by monitoring for any adverse events or serious adverse events.

The effectiveness of the treatment is evaluated by measuring the duration of viral suppression and the time to re-starting ART if necessary.

6 long-term follow-up

Participants are followed up every 12 weeks until the end of the study to monitor long-term outcomes, including CD4 counts and viral load.

The study aims to conclude by March 2027.

Who Can Join the Study?

Must be between 18 and 60 years old.
Current CD4 count should be more than 500 cells per microliter, or the CD4: CD8 ratio should be greater than 1.0. CD4 and CD8 are types of white blood cells important for the immune system.
Should be on a specific type of HIV treatment called an integrase inhibitor or a boosted protease inhibitor at the time of joining the study. If previously on a different type of treatment called non-nucleoside reverse transcriptase inhibitor, they must have switched at least 4 weeks before joining.
Must have adequate hemoglobin levels: at least 12 grams per deciliter for males and 11 grams per deciliter for females. Hemoglobin is a protein in red blood cells that carries oxygen.
Must weigh at least 50 kilograms.
Must have been vaccinated against COVID-19 at least 4 weeks before joining the study.
Females who can become pregnant must agree to use birth control methods or abstain from sex starting at least two weeks before the first infusion and for 20 months after the last infusion.
Must be able to give written consent and agree to long-term follow-up.
Must be willing and able to attend scheduled visits and provide blood samples.
Must have started ART (antiretroviral therapy) within six months of the estimated time of primary or early-stage infection. The estimated time of infection is based on specific criteria, such as test results showing recent infection.
Alternatively, must have started ART in early-stage infection, with a nadir CD4 count greater than 500 cells and stable on ART with undetectable HIV viral load for at least one year. Nadir CD4 is the lowest point the CD4 count has reached.
No evidence of the virus being resistant to the specific antibodies used in the study, based on a special test called proviral sequencing.
Must test negative for HBV (Hepatitis B Virus) and HCV (Hepatitis C Virus) or have negative results for specific antibodies.
Must not have any significant other health conditions.
For those diagnosed with confirmed PHI (Primary HIV Infection), the nadir CD4 count should be more than 250 cells per microliter.

Who Cannot Join the Study?

Individuals who do not have HIV cannot participate. HIV is a virus that affects the immune system.
Participants must be within a specific age range, which is not specified here.
Both males and females are eligible, so gender is not a reason for exclusion.
Vulnerable populations, such as those who might not be able to give informed consent, are not included in this study.

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
Universitair Ziekenhuis Gent	Gent	Belgium
Karolinska University Hospital	Solna	Sweden
Deutsches Herzzentrum Berlin	Berlin	Germany
Epixoey Ujxxagxrmtof Mabooro Czydlns Riyltsrgy (aisangw Mgd	Rotterdam	The Netherlands
Abmjed Uawfyyajrs Hmhgnmnk	Aarhus	Denmark
Hnyvieiu Ujrgdwfeoueqf Hnchoszb Tzsvs y Pyymem Iyzmpakn Cnedla dzhlgobvoppovcxrp (wkpm	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	28.04.2023
Denmark	Recruiting	28.04.2023
Germany	Recruiting	28.04.2023
Spain	Recruiting	28.04.2023
Sweden	Recruiting	28.04.2023
The Netherlands	Recruiting	28.04.2023

Trial locations

Investigated drugs:

10-1074-LS is a long-acting antibody designed to target and neutralize the HIV virus. It is used in this trial to help control the virus in people who have been recently infected with HIV or are in the early stages of infection. The goal is to see if this antibody can maintain control of the virus without the need for continuous antiretroviral therapy (ART).

3BNC117-LS is another long-acting antibody used in combination with 10-1074-LS. It also targets the HIV virus, aiming to neutralize it and help maintain viral control. This antibody is part of the trial to evaluate its effectiveness in sustaining control of the virus when ART is paused.

Investigated diseases:

HIV infection

Human Immunodeficiency Virus (HIV) – HIV is a virus that attacks the body’s immune system, specifically the CD4 cells, which are a type of white blood cell. 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. As the virus progresses, it can lead to acquired immunodeficiency syndrome (AIDS), where the immune system is severely damaged. Without treatment, HIV can gradually weaken the immune system, making the body more susceptible to infections and certain cancers. The progression of the disease can vary greatly among individuals, with some experiencing rapid progression and others maintaining a stable condition for many years.

Trial ID:

2024-514564-13-00

Protocol code:

19IC5249

NCT ID:

NCT04319367

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of 10-1074-LS and Teropavimab in Controlling HIV in Patients with Early Stage HIV Infection

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?