Can two antibodies and a cancer drug free people with HIV from daily pills?
NCT ID NCT07820813
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing whether a combination of two long-acting HIV antibodies and a low dose of the cancer immunotherapy nivolumab can help people with HIV control the virus without antiretroviral therapy. The trial enrolls 90 adults whose HIV is already well suppressed on standard treatment. Participants stop their regular HIV medications and receive either the antibody-nivolumab combination or a placebo, while researchers track how long their immune systems keep the virus in check.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two long-acting broadly neutralizing antibodies (3BNC117-LS and 10-1074-LS) combined with low-dose nivolumab, an anti-PD-1 immunotherapy
- What this could lead to
- If it works, this approach could point toward a way for some people with HIV to stay virally suppressed without taking daily antiretroviral pills.
- What could go wrong
- This is a Phase 2 trial with 90 participants, so results may not apply broadly. Stopping antiretroviral therapy carries real risks, including viral rebound and immune decline, and the combination may not produce lasting control.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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: * Ability and willingness to provide informed consent * HBV sAg or HBV DNA as well as HCV Ag or HCV RNA negative or anti-core antibody negative * Current CD4 count \>500 cells/μL (at screening) * Plasma HIV-1 RNA \<50 copies/mL by standard assays for at least 15 months (a single measurement \>50 but \<500 copies/mL during this time period is allowable) * On integrase inhibitor (INSTI) or boosted protease inhibitor (PI) based regimen at time of randomization, if previously on non-nucleoside reverse transcriptase inhibitor (NNRTI) has switched at least 4 weeks prior to randomization * Females of childbearing potential (i.e., participants who have not been postmenopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative serum or urine pregnancy test monthly * Pregnancy prevention (heterosexual contact(s)): o Females must agree to use highly eWective contraceptive methods: Hormonal contraception, intrauterine device, or intrauterine hormone-releasing system from at least 2 weeks before the bNAb infusion and for entire trial period of 60 weeks and 15 months following the bNAb infusion * Transmission prevention * Participants must agree to use barrier prevention during ART interruption and until plasma HIV-1 RNA levels are resuppressed again following ART re-start * Partners of study participants should be willing to receive counselling on the need for PrEP according to national recommendations Exclusion Criteria: * Current, or history of: * Clinically significant cardiovascular disease (e.g., cardiac insuWiciency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death) * Malignancy, excluding non-melanoma skin cancers * Solid organ transplant * Autoimmune or antibody-mediated diseases (including not limited to type 1 diabetes mellitus, inflammatory bowel diseases, scleroderma, severe psoriasis, myocarditis, uveitis, pneumonitis, systemic lupus erythematosus, rheumatoid arthritis, optic neuritis, myasthenia gravis, adrenal insuWiciency, hypothyroidism and/or hyperthyroidism, autoimmune thyroiditis, sarcoidosis, and vitiligo) * Known hypersensitivity to the components of 3BNC117-LS, 10-1074-LS or nivolumab or their analogues * HIV-1 reservoir predicted resistant to neutralization by 10-1074 using genotypic analysis (as defined in section 11.3.2.9) * Known HIV-1 subtype CRF01-AE due to resistance to 10-1074-LS * Receipt of strong immunosuppressive or systemic chemotherapeutic agents within 28 days prior to screening * Laboratory abnormalities in the parameters listed below: * Estimated glomerular filtration rate (eGFR) \<60 mL/min * AST or ALT \>x1.25 upper limit of normal (ULN) * Positive Quantiferon test * TPO antibodies \>35 IU/mL * Partial thromboplastin time \>1.25 ULN * Pregnancy or lactation * Any vaccination 2 weeks prior to baseline * Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness 2 weeks prior to screening * Have received a long-acting ART regimen within the last 12 months (e.g. cabotegravir or lenacaprivir containing regimen) * Known resistance to \>2 classes of ART * Participation in other interventional trial * Any other conditions, which in the opinion of the investigator would make the participant unsuitable for inclusion, or could interfere with the participants participating in or completion of the study
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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 official record
ClinicalTrials.gov lists the study team's own contact details, including names. 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.
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