Could antibody infusions replace daily HIV pills?
NCT ID NCT03526848
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 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: * 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Human immunodeficiency virus 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
-
Ragon Institute of MGH, MIT, and Harvard
Boston, Massachusetts, 02114, United States
-
The Rockefeller University
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tiny tweets, big impact? testing digital nudges to boost HIV prevention
- Can a phone app help young adults with HIV stay on track?
- Can a mouth rinse reveal hidden HPV risks in HIV patients?
- Could a single shot replace daily HIV pills?
- Walking groups could shield HIV-Positive latino men from heart disease
- Friends helping friends: a novel social-network strategy to boost HIV prevention