HIV-1Phase 2IDUNNNCT07820813
bNAbs and Anti-PD-1 in HIV
A Phase 2 study testing 3BNC117-LS, 10-1074-LS and Nivolumab in people with HIV-1, run by Ole Schmeltz Søgaard.
Trial summary
Antiretroviral therapy (ART) has significantly extended the life expectancy of people living with HIV-1 (PLWH), but it does not cure the infection. Broadly neutralizing antibodies (bNAbs), such as 3BNC117 and 10-1074, not only neutralize circulating virus but also engage the immune system to enhance HIV-1-specific… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1
- What is being tested?
- 3BNC117-LS, 10-1074-LS and Nivolumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ole S Søgaard, Professor contact
About this study
Official title: Inducing Durable Immunological Control of HIV-1 Through Administration of Long-acting Broadly Neutralizing Antibodies and Low-dose Anti-PD-1 - a Randomized, Double-blinded, Placebocontrolled Trial (the IDUNN Trial)
Antiretroviral therapy (ART) has significantly extended the life expectancy of people living with HIV-1 (PLWH), but it does not cure the infection. Broadly neutralizing antibodies (bNAbs), such as 3BNC117 and 10-1074, not only neutralize circulating virus but also engage the immune system to enhance HIV-1-specific CD8+ T cell responses and stimulate autologous neutralizing antibody production. In some individuals who discontinue ART, bNAb treatment resulted in long-term post-treatment control. However, a major obstacle to immunotherapeutic strategies in PLWH is the immune dysfunction that persists despite long-term suppressive ART. One contributing factor is the immune checkpoint receptor programmed death-1 (PD-1), which is expressed on T cells and suppresses their function when engaged by its ligands. Blocking PD-1 with monoclonal antibodies (mAbs) can reverse T cell exhaustion, a strategy that has resulted in extraordinary increases in survival and cure in cancer treatment and in ex vivo and animal studies of HIV. These findings support the rationale for incorporating PD-1 inhibition in HIV cure strategies. Low-dose nivolumab, an anti-PD-1 mAb, has been shown to be safe in clinical trials. The hypothesis is that combining a single low-dose of nivolumab with long-acting bNAbs (3BNC117-LS and 10-1074-LS) during an analytical treatment interruption (ATI) will reduce T cell exhaustion and boost HIV-1-specific immune responses, as a novel strategy to induce sustained virological control without ART even after the bNAbs have been cleared from the body.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3BNC117-LSDrug
bNAb; 30 mg/kg
10-1074-LSDrug
bNAb; 10 mg/kg
NivolumabDrug
Anti-PD-1a; low dose 1.0 mg/kg
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| A: bNAbs/anti-PD-1a | Experimental | 3BNC117-LS, 10-1074-LS and nivolumab Receives: Drug: 3BNC117-LS; Drug: 10-1074-LS; Drug: Nivolumab |
| B: bNAbs/placebo | Active comparator | 3BNC117-LS, 10-1074-LS and placebo Receives: Drug: 3BNC117-LS; Drug: 10-1074-LS; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the day of stopping ART to the day of meeting criteria for loss of immunological control of HIV-1 (defined below)
Loss of immunological control of HIV-1 is defined as one or more of the following three criteria:
- Six weeks of consecutive plasma HIV-1 RNA >1,000 copies/mL or confirmed >100,000 copies/mL
- Confirmed (on two consecutive measurements) CD4+ T cell count <350 cells/mm3
- Participant's request or if the ATI in the opinion of the Sponsor or Investigator poses an unacceptable risk to the participant
Measured: 60 weeks
Secondary outcomes (7)
The safety and tolerability of the Investigational Medicinal Products (IMPs)
Frequency and severity of adverse events (AEs), serious AEs (SAEs). Relationship to study drug and severity will be graded according to Division of AIDS (DAIDS) Grading Table, v2.1
Measured: Adverse events will be recorded from signing of the informed consent form and until end of study week 60 or visit 50 following restart of ART, whichever comes first.
The frequency of post-interventional immunological control of HIV-1
Durable immunological control of HIV-1 as defined in the primary outcome
Measured: At week 24, 36, 48 and 60
The effect of the IMPs on HIV-1-specific T cells responses before, during and after the ATI
Changes in HIV-1-specific T cell responses as measured by flow cytometry, T cell Elispot, and lymphocyte proliferation.
Measured: From baseline to weeks 8, 12, 16, 24 and 60 or ART-restart, whichever comes first
The effect of the IMPs on the intact HIV-1 reservoir before, during and after the ATI
Changes in the levels of intact proviral HIV-1 DNA per million CD4+ T cells as measured by PCR-based techniques
Measured: From baseline to weeks 24 and 60 or ART-restart, whichever comes first
The effect of the IMPs on the immune cell phenotype, activation and exhaustion
Changes in the distribution of immune cell subsets, activation and exhaustion markers as measured by flow cytometry
Measured: From baseline to weeks 8, 16, 24 and 60 or ART-restart, whichever comes first
The effect of autologous antibodies on post-interventional immunological control of HIV-1
Changes in autologous neutralizing antibody titers from baseline as determined by ex vivo neutralization assays
Measured: Time from the day of stopping ART to weeks 24 and 60 or day of restarting ART, whichever comes first
bNAb sensitivity
Proviral DNA/plasma virus bNAb sensitivity by genotypic or phenotypic analyses
Measured: Baseline and time of ART re-initiation (visit 30) during the 60 weeks of ATI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2029 (estimated)
- Study completion15 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ole Schmeltz Søgaard
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Aalborg University Hospital, Gødstrup Hospital, Odense University Hospital, Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet, Oslo University Hospital, Karolinska University Hospital, Landspitali University Hospital, Royal Prince Alfred Hospital, Sydney, Australia
- Responsible party
- Sponsor-investigator, Ole Schmeltz Søgaard, Aarhus University Hospital
- Investigators
- James McMahon, Professor, Study chair, Alfred Hospital; Monash UniversityJesper D Gunst, Ass. professor, Study chair, Aarhus University; Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820813
- Sponsor's protocol ID
- IDUNN-001
- Other IDs
- 2025-523725-17-00, 2025
- Acronym
- IDUNN
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inducing Durable Immunological Control of HIV-1 Through Administration of Long-acting Broadly Neutralizing Antibodies and Low-dose Anti-PD-1 - a Randomized, Double-blinded, Placebocontrolled Trial (the IDUNN Trial)
- ClinicalTrials.gov ID
- NCT07820813
- Acronym / sponsor ID
- IDUNN / IDUNN-001
- Conditions
- HIV-1
- Keywords
- HIV-1, IDUNN, bNAbs, 3BNC117-LS, 10-1074-LS, anti-PD-1, nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ole Schmeltz SøgaardUniversity, hospital or other
- Collaborators
- Monash University, Aalborg University Hospital, Gødstrup Hospital, Odense University Hospital, Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet, Oslo University Hospital, Karolinska University Hospital, Landspitali University Hospital, Royal Prince Alfred Hospital, Sydney, Australia
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Sep 2029 (estimated)
- Study completion
- 15 Sep 2030 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antiretroviral therapy (ART) has significantly extended the life expectancy of people living with HIV-1 (PLWH), but it does not cure the infection. Broadly neutralizing antibodies (bNAbs), such as 3BNC117 and 10-1074, not only neutralize circulating virus but also engage the immune system to enhance HIV-1-specific CD8+ T cell responses and stimulate autologous neutralizing antibody production. In some individuals who discontinue ART, bNAb treatment resulted in long-term post-treatment control. However, a major obstacle to immunotherapeutic strategies in PLWH is the immune dysfunction that persists despite long-term suppressive ART. One contributing factor is the immune checkpoint receptor programmed death-1 (PD-1), which is expressed on T cells and suppresses their function when engaged by its ligands. Blocking PD-1 with monoclonal antibodies (mAbs) can reverse T cell exhaustion, a strategy that has resulted in extraordinary increases in survival and cure in cancer treatment and in ex vivo and animal studies of HIV. These findings support the rationale for incorporating PD-1 inhibition in HIV cure strategies. Low-dose nivolumab, an anti-PD-1 mAb, has been shown to be safe in clinical trials. The hypothesis is that combining a single low-dose of nivolumab with long-acting bNAbs (3BNC117-LS and 10-1074-LS) during an analytical treatment interruption (ATI) will reduce T cell exhaustion and boost HIV-1-specific immune responses, as a novel strategy to induce sustained virological control without ART even after the bNAbs have been cleared from the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: bNAbs/anti-PD-1a | Experimental | Drug: 3BNC117-LS, Drug: 10-1074-LS, Drug: Nivolumab3BNC117-LS, 10-1074-LS and nivolumab |
| B: bNAbs/placebo | Active comparator | Drug: 3BNC117-LS, Drug: 10-1074-LS, Other: Placebo3BNC117-LS, 10-1074-LS and placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3BNC117-LSbNAb; 30 mg/kg | Drug | A: bNAbs/anti-PD-1a, B: bNAbs/placebo |
| 10-1074-LSbNAb; 10 mg/kg | Drug | A: bNAbs/anti-PD-1a, B: bNAbs/placebo |
| NivolumabAnti-PD-1a; low dose 1.0 mg/kg | Drug | A: bNAbs/anti-PD-1a |
| PlaceboSaline | Other | B: bNAbs/placebo |
Primary outcome
Time from the day of stopping ART to the day of meeting criteria for loss of immunological control of HIV-1 (defined below)
Time frame: 60 weeks
Loss of immunological control of HIV-1 is defined as one or more of the following three criteria: * Six weeks of consecutive plasma HIV-1 RNA >1,000 copies/mL or confirmed >100,000 copies/mL * Confirmed (on two consecutive measurements) CD4+ T cell count <350 cells/mm3 * Participant's request or if the ATI in the opinion of the Sponsor or Investigator poses an unacceptable risk to the participant
7 secondary outcomes
The safety and tolerability of the Investigational Medicinal Products (IMPs)
Time frame: Adverse events will be recorded from signing of the informed consent form and until end of study week 60 or visit 50 following restart of ART, whichever comes first.
The frequency of post-interventional immunological control of HIV-1
Time frame: At week 24, 36, 48 and 60
The effect of the IMPs on HIV-1-specific T cells responses before, during and after the ATI
Time frame: From baseline to weeks 8, 12, 16, 24 and 60 or ART-restart, whichever comes first
The effect of the IMPs on the intact HIV-1 reservoir before, during and after the ATI
Time frame: From baseline to weeks 24 and 60 or ART-restart, whichever comes first
The effect of the IMPs on the immune cell phenotype, activation and exhaustion
Time frame: From baseline to weeks 8, 16, 24 and 60 or ART-restart, whichever comes first
The effect of autologous antibodies on post-interventional immunological control of HIV-1
Time frame: Time from the day of stopping ART to weeks 24 and 60 or day of restarting ART, whichever comes first
bNAb sensitivity
Time frame: Baseline and time of ART re-initiation (visit 30) during the 60 weeks of ATI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ole S Søgaard, Professor contact
James McMahon, Professor study chair
Alfred Hospital; Monash University
Jesper D Gunst, Ass. professor study chair
Aarhus University; Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3BNC117-LS, 10-1074-LS and Nivolumab in people with HIV-1, run by Ole Schmeltz Søgaard.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ole S Søgaard, Professor (olesoega@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from the day of stopping ART to the day of meeting criteria for loss of immunological control of HIV-1 (defined below) (time frame: 60 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.