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Could antibody infusions replace daily HIV pills?

NCT ID NCT03526848

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested whether two lab-made antibodies (3BNC117 and 10-1074) could help people with HIV control the virus after stopping their daily antiretroviral therapy (ART). Twenty-six participants on stable ART received seven infusions of the antibodies, then paused their regular HIV medications. Researchers monitored how long it took for the virus to come back and checked for side effects. The goal was to see if these antibodies could keep the virus in check without daily pills.

What this could mean

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

Active substance
3BNC117 and 10-1074 (monoclonal antibodies)
What this could lead to
If successful, this could point toward a way for people with HIV to control the virus without needing daily antiretroviral therapy.
What could go wrong
This is a very early, small phase 1 trial with only 26 participants. The antibodies may not prevent viral rebound, and the effects may not last. There is also a risk of infusion reactions or other side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

26 people

The number who actually took part.

Started

Jun 2018

Finished

Feb 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

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.

Inclusion Criteria: * Male and females, age 18 to 65. * Confirmed HIV-1 infection. * On antiretroviral therapy with plasma HIV-1 RNA levels of \< 50 copies/ml for at least 12 months, and \< 20 copies/ml at screening. Note: a single viral load measurement \> 50 but \< 500 copies/ml during this time period is allowed. * Current CD4+ T cell counts \> 500 cells/μl and CD4+ T cell count nadir of \> 200 cells/μl. * If on an NNRTI-based regimen, willing to switch to an integrase inhibitor-based regimen for at least 4 weeks prior to discontinuing ART * If sexually active male or female, participating in sexual activity that could lead to pregnancy and of reproductive potential, agrees to follow the contraception requirements outlined Section 6.12.12 Family Planning Counseling. Participants should also agree to use a male or female condom while off ART to prevent infecting sexual partners. Exclusion Criteria: * Have a history of AIDS-defining illness within 3 years prior to enrollment. * History of systemic corticosteroids (long term use), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 6 months. * Any clinically significant acute or chronic medical condition (such as autoimmune diseases), other than HIV infection, that in the opinion of the investigator would preclude participation. * Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood. * History of resistance to 2 or more classes of antiretroviral medication. * Laboratory abnormalities in the parameters listed below: * Absolute neutrophil count ≤ 1,000 cells/μl * Hemoglobin ≤ 10 gm/dL * Platelet count ≤ 100,000 cells/μl * Alanine aminotransferase (ALT) ≥ 1.5 x ULN * Aspartate aminotransferase (AST) ≥ 1.5 x ULN * Alkaline phosphatase ≥ 1.5 x ULN * Total bilirubin ≥ 1.5 x ULN * eGFR \< 60 mL/min/1.73m2 * Prothrombin time (PT) \> 1.2 x upper limit of normal (ULN). (only if LN biopsies are performed) * Partial Thromboplastin Time (PTT) \> 1.2 x upper limit of normal (ULN) (only if LN biopsies are performed) * Pregnancy or lactation * Receipt of any therapeutic HIV vaccine or anti-HIV monoclonal antibody therapy in the past. * Participants with known hypersensitivity to any constituent of the investigational products. * Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study. * History of intolerance, sensitivity, allergy or anaphylaxis to benzodiazepines or other narcotics to be used during LN biopsy. (only if LN biopsies are performed) * Previous adverse reaction or allergy to lidocaine or other amide anesthetics, as well as benzocaine or other ester type anesthetics. (only if LN biopsies are performed) * History of underlying medical condition for which antibiotic prophylaxis for invasive procedures is required (only if LN biopsies are performed) * Currently taking anticoagulants including but not limited to: heparin (Hep-Lock, Hep-Pak, Hep-Pak CVC, Heparin Lock Flush), warfarin (Coumadin), tinzaparin (Innohep), enoxaparin (Lovenox), danaparoid (Orgaran), dalteparin (Fragmin), clopidogrel (Plavix), dipyridamole (Persantine), fondaparinux (Arixtra), argatroban (Agratroban), and bivalrudin (Angiomax). Prophylactic aspirin and regular NSAID use permitted. (only if LN biopsies are performed)

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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

  • Ragon Institute of MGH, MIT, and Harvard

    Boston, Massachusetts, 02114, United States

  • The Rockefeller University

    New York, New York, 10065, United States

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