Study of teropavimab (3BNC117-LS) and 10-1074-LS antibodies combined with antiretroviral therapy in patients with primary HIV-1 infection to evaluate viral control

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What is this study about?

This study focuses on people with primary HIV-1 infection. The research examines the effectiveness of combining standard antiretroviral therapy (ART) with two special antibodies called 3BNC117-LS and 10-1074-LS. These antibodies are designed to fight against the HIV virus and are given through an intravenous infusion.

The purpose of this research is to determine if adding these antibodies to regular HIV treatment can help control the virus better when the standard treatment is later stopped. During the study, participants will receive either the antibody treatment along with standard HIV medication, or standard HIV medication with a placebo. The antibodies or placebo will be given through an infusion into a vein.

After receiving treatment for 52 or 76 weeks, the regular HIV medication will be temporarily stopped to see how well the body controls the virus. Throughout the study, doctors will monitor the amount of virus in the blood and the body’s immune response. Sodium chloride solution will be used during the infusion process to help deliver the medication.

1 Initial treatment phase

You will begin antiretroviral therapy (ART) – standard HIV treatment that helps control the virus

Between 7-10 days after starting ART, you will receive two medications through intravenous infusion (directly into your vein):

– 3BNC117-LS (teropavimab)

– 10-1074-LS

Some participants will receive these medications, while others will receive a placebo (inactive substance)

2 Treatment monitoring period

You will continue taking ART medication for 52-76 weeks

During this time, regular blood tests will monitor:

– Levels of HIV in your blood (viral load)

– Your immune system status (CD4 and CD8 cell counts)

– Presence of the study medications in your blood

Your overall health and any side effects will be monitored

3 Treatment interruption phase

After 52-76 weeks, the ART treatment will be temporarily stopped

Your health will be closely monitored for 24 weeks to see how your body responds

Blood tests will continue to check viral levels and immune system function

You must use effective contraception throughout this period

4 Final evaluation

After 24 weeks of treatment interruption, final assessments will determine:

– If HIV levels remain below 400 copies/mL without ART

– Changes in your immune system

– Overall health status

Who Can Join the Study?

Must have a confirmed diagnosis of primary HIV-1 infection (either with symptoms or without) meeting one of these test criteria:
– Negative ELISA test or ELISA test without antibodies/p24 and positive HIV-1 RNA (confirmed twice)
– ELISA test without antibodies but with p24 (confirmed by positive HIV-1 RNA)
– Positive ELISA test with specific band patterns (confirmed by positive HIV-1 RNA)
Must have an HIV-1 RNA level of at least 10,000 copies per milliliter of blood
Must be between 18 and 70 years old when giving consent
Must agree to use effective contraception methods throughout the study (at least 52 weeks). This includes avoiding sperm donation for men and transgender women
For women and transgender men:
– Must have a negative pregnancy test
– Must agree not to try becoming pregnant through any means, including artificial insemination or in vitro fertilization, until completing all study visits
Must provide written informed consent
Must have regular health insurance (specific assistance programs not accepted)
Must be willing to:
– Travel to treatment centers for medication administration
– Stop HIV medication (antiretroviral therapy) when required by the study
Must agree to receive COVID-19 vaccination before stopping HIV medication
Must not have started HIV treatment before joining the study (except for preventive treatments known as pre- or post-exposure prophylaxis)

Who Cannot Join the Study?

Active or chronic hepatitis B (inflammation of the liver caused by hepatitis B virus) or hepatitis C infection
History of severe allergic reactions or hypersensitivity (extreme sensitivity) to antibody treatments
Presence of other serious medical conditions that could interfere with the study procedures
Current pregnancy or breastfeeding
Use of immunosuppressive medications (drugs that lower the body’s immune response)
Active opportunistic infections (infections that occur more frequently in people with weakened immune systems)
History of cancer within the past 5 years, except for successfully treated skin cancer
Significant kidney or liver dysfunction
Active substance abuse or dependence that could interfere with study participation
Mental health conditions that could affect the ability to follow study procedures
Participation in other clinical trials within the past 30 days
Known resistance to current HIV medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hopital Necker Enfants Malades	Paris	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Tenon	Paris	France
Hôpital Avicenne	Bobigny	France
Hospital Foch	Suresnes	France
Hopital Beaujon	Clichy	France
Assistance Publique Hopitaux De Paris	Paris	France
Hopital Antoine Beclere	Clamart	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cnwwnh Hnmunbvzqcr Ivwoezuesciku dz Vjxkluyhef Semim Ggzaulv	Villeneuve-Saint-Georges	France
Rubhzckyktkbofml Hkqicycw	Garches	France
Axbycmstit Pvdwfixv Hnmrpybb Df Ptvvt	Paris	France
Ccs Krgtbou Beqgwhj	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	11.04.2024

Trial locations

Investigated drugs:

3BNC117-LS is a laboratory-produced antibody designed to target and neutralize HIV-1. It is a long-acting antibody that helps fight the virus by recognizing and attaching to specific parts of HIV, potentially preventing it from infecting new cells and spreading in the body.

10-1074-LS is another laboratory-produced antibody that works together with 3BNC117-LS to fight HIV-1. This long-acting antibody targets a different part of the virus, creating a two-pronged approach to help control HIV infection.

Antiretroviral therapy (ART) is the standard treatment for HIV infection. It consists of a combination of medications that work together to suppress the virus and prevent it from multiplying in the body. This helps protect the immune system and reduces the risk of HIV-related complications.

HIV (Human Immunodeficiency Virus) – A viral infection that attacks the body’s immune system, specifically targeting CD4 cells (T cells) which help the immune system fight off infections. The virus progressively weakens the immune system over time by destroying these important cells. HIV spreads through certain body fluids including blood, semen, vaginal fluids, and breast milk. Initially, some people may experience flu-like symptoms shortly after infection, while others may not notice any symptoms. Without intervention, the virus continues to multiply and destroy CD4 cells, gradually diminishing the body’s natural defenses.

Trial ID:

2024-516150-22-00

Protocol code:

ANRS 176 RHIVIERA02

NCT ID:

NCT05300035

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of teropavimab (3BNC117-LS) and 10-1074-LS antibodies combined with antiretroviral therapy in patients with primary HIV-1 infection to evaluate viral control

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?