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Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1

Studying a new HIV treatment for safety and effectiveness in adults.

Recruiting
18 years and older
All
Phase 1/2

This study aims to test a new treatment plan for adults with HIV-1. It uses a mix of vaccines, antibodies, and a medicine called vesatolimod (VES) to see if it can help control the virus without regular HIV medicine. Participants will be given either the treatment or a placebo (a harmless substance that looks like the treatment) to compare results. The study includes several steps, each lasting a different amount of time.

In the first step, participants will receive treatment and continue their regular HIV medicine for about 67 weeks. Then, they will stop their regular medicine for up to 24 weeks to see if the new treatment can keep the virus under control. If the virus comes back, they will restart their medicine for another 24 weeks. If the virus stays under control, they will continue without medicine for another 24 weeks.

  • The study lasts up to 110 weeks.
  • Participants need to follow all study visits and rules.
  • Participants must have started HIV treatment soon after diagnosis.

Participants must meet certain health criteria to join, and women who can become pregnant must use birth control. People with certain medical conditions or allergies cannot participate.

Study details
    HIV-1-infection

NCT06071767

National Institute of Allergy and Infectious Diseases (NIAID)

30 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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