New antibody cocktail aims to block HIV without daily pills
NCT ID NCT07390955
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times
Summary
This early-stage trial is testing whether lab-made antibodies that target HIV are safe and how long they stay in the body. About 83 healthy adults without HIV will receive the antibodies by vein or under the skin, alone or in combination. The goal is to find the right dose and check for side effects, not to treat HIV yet.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lab-made antibodies (ePGT121v1-LS, PGDM1400LS, VRC07-523LS)
- What this could lead to
- If successful, this could point toward a new way to control HIV without daily pills, using periodic antibody infusions or shots.
- What could go wrong
- This is a very early Phase 1 safety study with only 83 healthy volunteers, not people with HIV. It is too soon to know if the antibodies will work against the virus in real-world conditions.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 83 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
Inclusion Criteria: 1. Age 18 to 55 years. 2. Can visit a participating clinic and is willing to stay in the study for its full duration. 3. Understands the study and is able and willing to give informed consent. 4. Agrees not to join another experimental study until the final required clinic visit. 5. In good overall health based on medical history, physical exam, and screening lab tests. 6. Willing to receive HIV test results. 7. Willing to discuss personal risk of getting HIV and to have HIV prevention counseling. 8. Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higher risk behaviors through the last clinic visit. 9. Hemoglobin levels: * Women: at least 11.0 g/dL * Men: at least 13.0 g/dL 10. White blood cell count between 2,500 and 12,000 cells/mm³. 11. White blood cell differential is normal or acceptable to clinic staff. 12. Platelet count between 125,000 and 550,000 cells/mm³. 13. ALT (liver enzyme) less than 1.25 times the lab's upper limit of normal. 14. Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal. 15. Negative tests for HIV 1 and HIV 2. 16. Negative hepatitis B surface antigen. 17. Negative hepatitis C antibody, or a negative HCV PCR if the antibody test is positive. 18. Urine protein is negative or only trace. 19. If a woman who could become pregnant: negative pregnancy test within 72 hours before the first study treatment. Women with a documented total hysterectomy, both ovaries removed, both fallopian tubes removed, or menopause (no periods for at least 1 year) do not need pregnancy testing. 20. Women who could become pregnant agree to use effective birth control for sex that could lead to pregnancy starting at least 21 days before enrollment and continuing through the last study visit. 21. Women who could become pregnant also agree not to try to become pregnant using methods like egg retrieval, artificial insemination, or in vitro fertilization starting at least 21 days before enrollment and continuing through the last clinic visit. Exclusion Criteria: 1. Received blood products within 120 days before the first study dose (unless the safety review team approves earlier enrollment). 2. Took any experimental (investigational) research drug within 30 days before the first study dose. 3. Weighs less than 35 kg or more than 115 kg. 4. Plans to join another study using an experimental product, or any study that requires non Network HIV antibody testing, during this study. 5. Pregnant or breastfeeding. 6. Previously received an HIV vaccine in a vaccine trial. If a potential participant received placebo/control only, eligibility will be decided case by case by the safety review team. 7. Received any non HIV vaccine within 14 days before enrollment or plan to get one within 14 days after enrollment. Exception: ACAM2000 smallpox vaccine within 28 days before enrollment (or scab still present if earlier) or planned within 14 days after enrollment. 8. Received humanized or human monoclonal antibodies (mAbs), whether approved or experimental. 9. Previously received monoclonal antibodies that target HIV. 10. Receiving allergy shots within 30 days before the first study dose or scheduled within 14 days after the first dose. 11. Took immune suppressing medicines within 30 days before the first study dose. Not excluded: nasal steroid sprays; inhaled steroids (see asthma item); topical steroids for mild skin conditions; or one short course of oral/IV prednisone (less than 20 mg/day for under 14 days) finished at least 7 days before the first infusion/injection. 12. History of serious reactions to components of the study products, including anaphylaxis or symptoms like hives, trouble breathing, swelling (angioedema), or abdominal pain. 13. Received immunoglobulin within 60 days before the first study dose (separate from mAbs listed above). 14. Autoimmune disease that is not mild, stable, and uncomplicated. Mild, stable cases not needing immune suppressing drugs may be allowed if the investigator judges low risk. 15. Immunodeficiency. 16. Any significant medical issue, abnormal exam or lab result, or past condition that could: * Affect the immune system or its response, * Require medicines that affect the immune system, * Make repeated injections, infusions, or blood draws unsafe or not feasible (for example, very difficult veins), * Need active medical care to prevent serious harm during the study, * Have symptoms that could be mistaken for reactions to the study product, * Or is otherwise listed among these exclusions. 17. Any medical or skin condition, social situation, or job duty that, in the investigator's judgment, would interfere with following the study, safety assessments, or giving informed consent. 18. A psychiatric condition that prevents following the study. Specifically excluded: psychosis, current suicide risk, or a suicide attempt within the past 3 years. 19. Currently on tuberculosis treatment. 20. Asthma that is more than mild and well controlled. 21. Diabetes (type 1 or type 2). Not excluded: type 2 controlled with diet only, or a past history of gestational diabetes. 22. High blood pressure (hypertension). 23. Diagnosed bleeding disorder. 24. Cancer. Not excluded: surgically removed cancers with good assurance of cure or very low risk of recurrence during the study period. 25. Seizure disorder with any seizure in the past 3 years, or use of seizure prevention or seizure treatment medicines at any time in the past 3 years. 26. Asplenia (no functioning spleen). 27. History of widespread hives, swelling (angioedema), or anaphylaxis. Not excluded if due to a known trigger and there have been no reactions for at least 5 years, showing successful avoidance of the trigger.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alabama CRS (Site ID: 31788)
RECRUITINGBirmingham, Alabama, 35222, United States
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Bridge HIV CRS (Site ID: 30305)
RECRUITINGSan Francisco, California, 94102, United States
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Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)
NOT_YET_RECRUITINGBoston, Massachusetts, 02115, United States
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Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)
NOT_YET_RECRUITINGBellavista, Provincia Constitucional del Callao, 07006, Peru
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Houston Advancing Research Team CRS (Site ID: 31473)
RECRUITINGHouston, Texas, 77030, United States
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Penn Prevention CRS (Site ID: 30310)
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Seke South CRS (Site ID: 30294)
NOT_YET_RECRUITINGHarare, Zimbabwe
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Spilhaus CRS (Site ID: 30314)
NOT_YET_RECRUITINGHarare, Zimbabwe
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The Ponce de Leon Center CRS (Site ID: 5802)
NOT_YET_RECRUITINGAtlanta, Georgia, 30308, United States
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Vanderbilt Vaccine (VV) CRS (Site ID: 30352)
RECRUITINGNashville, Tennessee, 37232, United States
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Via Libre CRS (Site ID: 31909)
NOT_YET_RECRUITINGLima Cercado, Lima region, 15001, Peru
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