Ongoing Clinical Trials for Acute HIV Infection
There is currently 1 ongoing clinical trial investigating new treatment approaches for acute HIV infection. This trial is exploring the use of long-acting antibodies to help control the virus in people who have been recently diagnosed. The study is being conducted across multiple European countries and aims to determine whether these antibodies can maintain viral control without the need for continuous standard medication.
Clinical trial locations
- Denmark
- Netherlands
- Spain
- Sweden
Study on the Effectiveness of 10-1074-LS and Teropavimab in Controlling HIV in Patients with Early Stage HIV Infection
This trial, known as the RIO Trial, is investigating whether two special types of proteins called broadly neutralizing antibodies can help control HIV in people who have been recently diagnosed with the infection. The study is testing whether these antibodies, named 10-1074-LS and 3BNC117-LS, can maintain control of the virus without the need for continuous standard antiretroviral therapy.
Main focus and goal: The trial aims to observe how well these antibodies work in keeping the virus under control over a period of 20 weeks after stopping standard treatment. Participants 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 will monitor the safety of the treatment by checking for any side effects and will track how long the virus remains undetectable in the blood.
Who can participate: To join this study, participants must be between 18 and 60 years old and weigh at least 50 kilograms. They need to have a current CD4 count of more than 500 cells per microliter, or a CD4 to CD8 ratio greater than 1.0. CD4 and CD8 are types of white blood cells that are important for the immune system. Participants should already be on a specific type of HIV treatment called an integrase inhibitor or a boosted protease inhibitor. They must have started antiretroviral therapy within six months of their early infection, or if diagnosed earlier, they should have been stable on treatment with undetectable viral load for at least one year. Adequate hemoglobin levels are required, at least 12 grams per deciliter for males and 11 grams per deciliter for females. Participants must be vaccinated against COVID-19 at least four weeks before joining, and females who can become pregnant must agree to use birth control methods. They should test negative for Hepatitis B and Hepatitis C, have no significant other health conditions, and the virus must not show resistance to the antibodies being tested.
Who cannot participate: Individuals who do not have HIV cannot participate in this trial. Vulnerable populations who might not be able to give informed consent are also excluded from the study.
Investigational drugs: The two antibodies being tested are 10-1074-LS and 3BNC117-LS. Both are long-acting antibodies designed to target and neutralize the HIV virus. These antibodies work by binding to the virus and blocking its ability to infect new cells. The goal is to see if these antibodies can provide a new way to manage HIV without continuous medication, maintaining viral control when standard antiretroviral therapy is paused.
Summary
Currently, there is only one active clinical trial investigating new treatment approaches for acute HIV infection. This trial is being conducted across four European countries: Denmark, the Netherlands, Spain, and Sweden, offering opportunities for patients in these regions to participate. The study focuses on the use of two specific broadly neutralizing antibodies, 10-1074-LS and 3BNC117-LS, representing a novel approach to HIV management that aims to reduce reliance on continuous antiretroviral therapy. The trial is particularly notable for its focus on patients who have been recently diagnosed or are in the early stages of infection, with the goal of understanding whether antibody-based treatments can provide sustained viral control. The study is expected to conclude by March 2027, and its findings may contribute to the development of new treatment strategies for managing HIV.
