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Could two antibodies and a pill help women control HIV without daily drugs?

NCT ID NCT05281510

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two lab-made antibodies (VRC07-523LS and CAP256V2LS) and an immune-boosting pill (vesatolimod) in 20 women with HIV who were already on standard antiretroviral therapy. The goal was to see if the regimen is safe and might help control the virus after stopping daily meds. Participants were monitored for side effects and viral rebound.

What this could mean

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

Active substance
VRC07-523LS and CAP256V2LS (antibodies) plus vesatolimod (immune stimulant)
What this could lead to
If successful, this combination might help control HIV without daily pills, pointing toward long-term remission.
What could go wrong
This is a small, early-phase safety study with only 20 women. It may not lead to a practical treatment, and side effects from the immune stimulant or antibodies 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

20 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Key Inclusion Criteria: * Age ≥ 18 years * Females recruited from the Females Rising through Education, Support, and Health (FRESH) acute human immunodeficiency virus (HIV) infection cohort. * Plasma human immunodeficiency -1 (HIV-1) ribonucleic acid (RNA) levels \< 50 copies/mL at the screening visit. * On antiretroviral (ART) regimen for ≥ 12 consecutive months prior to the screening visit. * Have all the following laboratory values at the screening visit: * Hemoglobin ≥ 10.0 g/dL * White blood cells ≥ 2500 cells/μL * Platelets ≥ 125,000/mL * Absolute neutrophil counts ≥ 1000 cells/μL * Cluster of differentiation (CD)4+ T cell count ≥ 500 cells/μL * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin ≤ 2 × upper limit of normal (ULN) * Creatinine clearance ≥ 60 mL/min * Women of childbearing potential to have documentation of agreement to follow study contraceptive requirements. * Documented plasma HIV-1 RNA \< 50 copies/mL for 12 consecutive months prior to the screening visit. * In the judgment of the investigator, be in good general health. * Documented history of viral sensitivity to VRC07-523LS or CAP256V2LS at the screening visit. Key Exclusion Criteria: * Have poor venous access that limits phlebotomy. * Positive serum pregnancy test. * Nursing participants. * Females with coinfection and/or immunosuppression as described below: * Autoimmune disease requiring ongoing immunosuppression * Evidence of chronic hepatitis B virus (HBV) infection * Evidence of current hepatitis C virus (HCV) infection * Documented history of pre-ART CD4+ T cell count nadir \< 200 cells/μL * History of opportunistic illness indicative of Stage 3 HIV * Acute febrile illness within 4 weeks prior to the first dose * Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance or individual's safety. * Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or are expected to receive these agents during the study. * Have previous or current receipt of humanized or human monoclonal antibody (mAbs), or polyclonal immunoglobulin. * Have previous history of an antidrug antibodies response to a therapeutic agent. * Have previous receipt of an HIV vaccine. * Received any vaccine or immunomodulatory medication within 4 weeks prior to screening. * Have a history of any of the following: * Significant serious skin disease * Significant drug sensitivity or drug allergy * Known hypersensitivity to the study drugs, metabolites, or formulation excipients * Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia * Autoimmune diseases including type 1 diabetes mellitus * Have current Class C acquired immunodeficiency syndrome (AIDS)-defining condition. * Have any serious or active medical or psychiatric illness that would interfere with participants treatment, assessment, or compliance with the protocol. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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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

  • FRESH Clinical Research Site: Females Rising through Education, Support and Health

    Umlazi, 4066, South Africa

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