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Could antibody infusions help prevent HIV? new trial begins

NCT ID NCT06812494

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This phase 2 trial is testing whether a combination of three lab-made antibodies is safe and tolerable in 200 healthy adults without HIV. Participants receive one or more IV infusions of the antibodies and are followed for 18 months. The goal is to see if this approach could eventually be used to prevent or control HIV infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
three lab-made antibodies (VRC07-523LS, PGT121.414.LS, PGDM1400LS) given by IV infusion
What this could lead to
If successful, this could point toward a new way to prevent or control HIV using infusions of antibodies instead of daily pills.
What could go wrong
This is an early phase 2 trial focused on safety, so it is not yet testing whether the antibodies actually prevent HIV. The antibodies may not work as hoped, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants need to be between 18 and 65 years old. * Participants must have access to a participating clinical research site and be willing to follow the study schedule. * Participants should understand the study details and be willing to give informed consent. * Participants must agree not to join any other clinical trials until they finish this study. * Participants must be willing to receive HIV test results. * Participants should be open to discussing HIV prevention. * Clinic staff should assess participants as having a low risk of getting HIV, and participants must commit to avoiding high-risk behaviors during the study. * Hemoglobin: Participant meets minimum levels depending on gender and hormone therapy status. * White Blood Cells (WBC): Should be within the normal range or approved by a site clinician. * Platelets: At least 100,000 cells/mm³. * Alanine aminotransferase (ALT): Less than 5 times the upper normal limit. * Creatinine: Less than 1.8 times the upper normal limit or less than 1.5 times your baseline level. * Participants must test negative for HIV-1 and HIV-2. * Participants urine protein must be negative or trace. Reproductive Status: * Participants of child-bearing potential need a negative pregnancy test within 72 hours before starting the study. * Participants must agree to use effective birth control from at least 21 days before joining the study until the end of the study. * Participants must agree not to try to become pregnant through any method during the study. Exclusion Criteria: * Participants cannot have had a blood transfusion within the last 120 days. * Participants cannot have received experimental treatments within the last 30 days. * Participants cannot weigh less than 35 kg (about 77 lbs). * Participants cannot plan to join another clinical trial during this study. * Participants cannot be pregnant or breastfeeding. * Participants cannot have received an HIV vaccine in a previous trial (unless it was a placebo, subject to Protocol Safety Review Team's approval). * Participants cannot have had any live vaccines within the last 14 days or non-live vaccines within the last 7 days. * Participants cannot have had humanized or human monoclonal antibodies recently, except for certain HIV antibodies more than 12 months ago. * Participants cannot have had allergy shots within the last 14 days. * Participants cannot have taken immunosuppressive drugs within the last 30 days, with some exceptions like nasal sprays or mild skin treatments. * Participants cannot participate if they have had serious allergic reactions to the components of the study product. * Participants cannot have received immunoglobulin within the last 60 days. * Participants cannot have an autoimmune disease that requires immunosuppressive treatment, unless it's mild and stable. * Participants cannot have an immune system deficiency. * Participants cannot have any significant medical condition or abnormal lab results that could impact their health during the study. * Participants cannot have conditions that make repeated injections or blood draws difficult. * Participants cannot have conditions requiring active medical treatment that could pose a risk during the study. * Participants cannot have conditions that could be confused with reactions to the study product. * Participants cannot have medical, social, or occupational conditions that would interfere with the study. * Participants cannot have severe psychiatric conditions, like ongoing risk of suicide or recent history of suicide attempts. * Participants cannot be undergoing treatment for tuberculosis. * Participants cannot have severe asthma that requires frequent medication or emergency care. * Participants cannot have diabetes mellitus (DM) (well-controlled Type 2 DM or an isolated history of gestational diabetes are not exclusionary). * Participants blood pressure must be below 160/110 mmHg. * Participants cannot have any diagnosed bleeding disorders. * Participants cannot have active cancer but may be eligible if, in the investigator's estimation, they have a reasonable assurance of sustained cure, or are unlikely to experience recurrence of malignancy during the period of the study * Participants cannot have had seizures or taken seizure medications in the past 3 years. * Participants cannot have a history of severe allergic reactions like anaphylaxis, unless it has been well-controlled for at least 5 years. * Participants cannot have acute or unstable hepatitis B or C, but stable chronic cases may be considered.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Alabama CRA (Site #31788)

    Birmingham, Alabama, 35222, United States

  • BIDMC VCRS (Site ID# 32077)

    Boston, Massachusetts, 02215, United States

  • Bridge HIV, San Francisco Department of Public Health

    San Francisco, California, 94102, United States

  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

    Boston, Massachusetts, 02115-6110, United States

  • CITBM CRS (Site ID 31970)

    Callao, Provincia Constitucional del Callao, 15081, Peru

  • Chapel Hill CRS (Site #3201)

    Chapel Hill, North Carolina, 27599, United States

  • Columbia P&S CRS

    New York, New York, 10032, United States

  • Fenway Health

    Boston, Massachusetts, 02215-4302, United States

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104, United States

  • San Miguel CRS (Site #11302)

    Lima, 32-15088, Peru

  • Seattle Vaccine and Prevention CRS (Site ID# 30331)

    Seattle, Washington, 98104, United States

  • The Hope Clinic of the Emory Vaccine Research Center; Emory University

    Decatur, Georgia, 30030, United States

  • University of Pittsburgh CRS (Site 1001)

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)

    Rochester, New York, 14642, United States

  • Vanderbilt Vaccine (VV) CRS

    Nashville, Tennessee, 37232, United States

  • Via Libre (Site ID 31909)

    Lima, Lima Province, 15001, Peru

More trials for these conditions

Other studies related to the condition(s) this trial covers.