Could two antibodies and a pill help women control HIV without daily drugs?
NCT ID NCT05281510
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HIV-1-infection are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can fewer HIV drugs keep the virus just as suppressed?
- HIV cure clue: does early treatment shrink the hidden virus?
- Can a cancer drug flush out hidden HIV?
- Can two antibodies and a cancer drug free people with HIV from daily pills?
- Do unsuppressed HIV infections fuel new cases in ethiopia?
- A simple idea to stop STIs: send treatment home with the patient