HIV-1Phase 1NCT05612178
A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy
A Phase 1 study testing 3BNC117-LS, 10-1074-LS and Sterile Saline in people with HIV-1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Background: Antiretroviral therapy (ART) can suppress HIV to undetectable levels in people, but the virus rebounds quickly if the drug treatment is stopped; this is because HIV can remain dormant in a pool of blood cells called the persistent viral reservoir (PVR). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV-1
- What is being tested?
- 3BNC117-LS, 10-1074-LS and Sterile Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2023to 31 Mar 2027
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability to provide informed consent;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Adult persons of any sex or gender, aged 18 years to 70;
- Confirmed HIV-1 infection and clinically stable;
- On antiretroviral therapy with plasma HIV-1 RNA levels of < 50 copies/mL and no reported interruption of ART for 7 consecutive days or longer for at least 96 weeks. NOTE: At least two viral load (VL) measurements within 48 weeks prior to the screening visit must be available for review. A single plasma HIV-1 RNA > 50 copies/mL but < 200 copies/mL over 48 weeks that is followed by an HIV-1 RNA < 50 copies/mL is permitted;
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- Current CD4+ T cell counts > 300 cells/mcL;
- For participants who can become pregnant (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), must have a negative pregnancy test at screening and within 48 hours prior to day 0; NOTE: Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy.
- Participants who can become pregnant must agree to use adequate measures to prevent pregnancy. This includes the use an effective method of contraception for the study duration. Contraception must be used from 10 days prior to the first dose of the investigational products (IPs), while receiving the IPs and during study follow up. Acceptable methods of contraception include:
- Contraceptive subdermal implant
- Intrauterine device or intrauterine system
- Combined estrogen and progestogen oral contraceptive
- Injectable progestogen
- Contraceptive vaginal ring
- Percutaneous contraceptive patches
- NOTE: Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant, will be allowed. The documentation of partner sterility can come from the site personnel s review of medical records, medical examination and/or semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.
- Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to the first dose of the IPs, while receiving the IPs and during study follow up to avoid impregnating a partner who can get pregnant.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- History of AIDS-defining illness within 3 years prior to enrollment;
- History of systemic corticosteroids (e.g., an equivalent dose of prednisone of > 20 mg daily for >14 days), 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 (e.g. such as autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), 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. NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible;
- Participants with known hypersensitivity to any constituent of the investigational products;
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- Pregnancy or lactation;
- ART initiated during acute infection (defined as p24, HIV nucleic acid amplification technique [NAAT], or HIV RNA PCR positive, and negative or indeterminate HIV antibody testing);
- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count < 1,000 cells/microliter
- Hemoglobin < 10 gm/dL
- Platelet count < 100,000 cells/microliter
- ALT > 1.5 x ULN
- AST > 1.5 x ULN
- Total bilirubin > 1.5 x ULN
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2
- Any history of receipt of HIV-1 mAb therapy or HIV vaccine;
- Participation in any clinical study of an investigational product within 12 weeks prior to study entry (day 0) or expected participation in such a study during this study;
- Any approved or experimental non-HIV vaccination (e.g., SARS-CoV-2, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment (day 0);
- Inability to undergo leukapheresis due to poor venous access or other medical conditions;
- Active drug or alcohol use or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
The Rockefeller University
New York, New York, 10065
About this study
Official title: A Randomized Placebo-controlled Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy
Background:
Antiretroviral therapy (ART) can suppress HIV to undetectable levels in people, but the virus rebounds quickly if the drug treatment is stopped; this is because HIV can remain dormant in a pool of blood cells called the persistent viral reservoir (PVR). Yet lifelong ART is expensive and can lead to serious side effects over the long term. Some drugs may be more effective at reducing the PVR.
Read more
Objective:
To see if 2 study drugs (3BNC117-LS and 10-1074-LS) are safe and if they can lower the number of HIV-infected blood cells in people with HIV who are on ART.
Eligibility:
People aged 18 to 70 years with HIV who are on ART.
Design:
Participants will be screened. They will have a physical exam and blood and urine tests. They will undergo leukapheresis. Leukapheresis is a procedure where blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm.
The study drugs or placebo (normal saline) will be administered 3 times at 20-week intervals. The drugs will be given through a tube attached to a needle inserted into a vein in the arm. This will take 1 hour. Some participants will receive only a saline solution. They will not know if they are getting the drugs or the placebo.
Participants will undergo leukapheresis up to 4 more times during the study.
Participants will have follow-up visits every 10 weeks until the study ends.
Read the detailed description
Study Description:
This is randomized placebo-controlled study of the safety and virologic activity of the 3BNC117-LS plus 10-1074-LS broadly neutralizing antibody (bNAb) combination during standard antiretroviral therapy (ART).
Participants will be enrolled sequentially and randomized to receive 3BNC117-LS plus 10-1074-LS or placebo (sterile saline) at a 1:1 ratio. Participants will receive two intravenous infusions of 3BNC117-LS (dosed at 30 mg/kg) and 10-1074-LS (dosed at 10 mg/kg) or placebo at weeks 0 and 20. Participants will remain on ART during the study.
Objectives:
Primary Objectives:
-To evaluate the safety and tolerability of repeated doses of 3BNC117-LS and 10-1074-LS in adults living with human immunodeficiency virus (HIV) during suppressive ART.
Secondary Objectives:
- To evaluate the impact of 3BNC117-LS and 10-1074-LS on intact human immunodeficiency type 1 (HIV-1) proviruses over time in adults living with HIV during suppressive ART.
- To determine the effects of repeated doses of 3BNC117-LS and 10- 1074-LS during suppressive ART on HIV-1 specific cellular immune responses by enzyme-linked immunosorbent spot (ELISpot).
- To describe the pharmacokinetic parameters of the repeated doses of 3BNC117-LS and 10-1074-LS in adults living with HIV during suppressive ART.
Exploratory Objectives:
- To characterize the HIV-1 reservoir in peripheral blood during and following repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
- To evaluate effects on HIV-1 transcriptional activity during and following repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
- To characterize host HIV-1 specific humoral, cellular and innate immune responses during and following repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
- To correlate HIV-1 specific immune responses and effects on intact proviruses.
- To correlate virologic outcomes with bNAb sensitivity of reservoir proviruses.
Endpoints:<TAB>
Primary Endpoints:
-The occurrence of solicited and unsolicited grade 3 or higher adverse events (AE) (including confirmed laboratory abnormalities) that are possibly, probably, or definitely related to 3BNC117-LS and/or 10- 1074-LS, or premature study treatment discontinuation due to an AE (regardless of grade).
Secondary Endpoints:
- The occurrence of serious adverse events, regardless of relationship to 3BNC117-LS and/or 10-1074-LS.
- Change in the intact proviral reservoir size, measured by quadruplex polymerase chain reaction (Q4PCR) and/or intact proviral deoxyribonucleic acid assay (IPDA), from baseline to weeks 40 and 80 after dosing with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Changes in HIV-1 specific T cell immune responses in peripheral blood, measured by ELISpot, before, during and after dosing with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Pharmacokinetic parameters (including: peak concentrations, half- life, area under curve and clearance rate) of repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
Exploratory Endpoints:
- Size of the latent HIV-1 reservoir, measured by quantitative viral outgrowth assay (QVOA) and/or other appropriate assays, before, during and after dosing with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Composition of the intact proviral reservoir before and after immunotherapy with 3BNC117-LS and 10-1074-LS during suppressive ART by Q4PCR or other appropriate assays that may become available.
- The half-life of the HIV-1 intact proviral reservoir during 3BNC117- LS and 10-1074-LS therapy and ART suppression.
- HIV-1 transcriptional activity as determined by spliced and unspliced HIV-1 ribonucleic acid (RNA) in circulating total CD4+ T cells and/or other appropriate assays, before, during and after dosing with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Changes in HIV-1 specific T cell immune responses in peripheral blood, measured by assays such as polyfunctional intracellular cytokine staining (ICS) and viral inhibition assay before, during and after immunotherapy with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Changes in antibody dependent cell-mediated cytotoxicity (ADCC) against HIV-1-infected CD4+ T-cells by ex vivo autologous natural killer cells before and after immunotherapy with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Correlation between magnitude, breadth and functionality of HIV-1 specific T cell immune responses and effects on intact proviruses.
- Correlation between changes in intact proviruses and bNAb sensitivity of reservoir proviruses determined by Env sequencing.
- Correlation between HIV-1 transcriptional activity and changes in the composition of the intact proviral reservoir.
- Conditions
- HIV-1
- Being tested
- 3BNC117-LS, 10-1074-LS, Sterile Saline
- Keywords
- bNAb, HIV Reservoir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3BNC117-LSBiological
Participants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10-1074-LS (dosed at 10 mg/kg) or placebo at weeks 0, 20 and 40.
10-1074-LSBiological
Participants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10- 1074-LS (dosed at 10 mg/kg) or placebo at weeks 0, 20 and 40.
Sterile SalineOther
Participants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10-1074-LS (dosed at 10 mg/kg) or placebo at weeks, 20 and 40.
| Study group | Role | What they receive |
|---|---|---|
| 3BNC117-LS and 10-1074-LS | Experimental | Participants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10-1074-LS (dosed at 10 mg/kg) at weeks 0, 20 and 40. Receives: Biological: 3BNC117-LS; Biological: 10-1074-LS |
| Placebo | Placebo comparator | Participants will receive three intravenous infusions of placebo (Sterile Saline) at weeks 0, 20 and 40. Receives: Other: Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited and unsolicited grade 3 or higher adverse events
The occurrence of solicited and unsolicited grade 3 or higher adverse events (AE) (including confirmed laboratory abnormalities) that are possibly, probably, or definitely related to 3BNC117-LS and/or 10-1074-LS, or premature study treatment discontinuation due to an AE (regardless of grade).
Measured: Week 0 to End of Study
Secondary outcomes (4)
Occurrence of Serious Adverse Events
The occurrence of serious adverse events, regardless of relationship to 3BNC117-LS and/or 10-1074-LS.
Measured: Week 0 to End of Study
Change in the intact proviral reservoir size
Change in the intact proviral reservoir size, measured by Q4PCR and /or IPDA, from baseline to weeks 40 and 80 after dosing with 3BNC117-LS and 10-1074-LS during
Measured: Baseline to Weeks 40 and 80
Changes in HIV-1 specific T cell immune responses in peripheral blood
Changes in HIV-1 specific T cell immune responses in peripheral blood, measured by ELISpot, before, during and after dosing with 3BNC117 LS and 10-1074-LS during suppressive ART.
Measured: Throughout
Pharmacokinetic parameters
Pharmacokinetic parameters (including: peak concentrations, halflife, area under curve and clearance rate) of repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
Measured: Throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start26 Jul 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael C Sneller, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612178
- Sponsor's protocol ID
- 10001037
- Other IDs
- 001037-I
- Status last verified
- 23 Sep 2026
- First submitted
- 9 Nov 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mendoza P, Gruell H, Nogueira L, Pai JA, Butler AL, Millard K, Lehmann C, Suarez I, Oliveira TY, Lorenzi JCC, Cohen YZ, Wyen C, Kummerle T, Karagounis T, Lu CL, Handl L, Unson-O'Brien C, Patel R, Ruping C, Schlotz M, Witmer-Pack M, Shimeliovich I, Kremer G, Thomas E, Seaton KE, Horowitz J, West AP Jr, Bjorkman PJ, Tomaras GD, Gulick RM, Pfeifer N, Fatkenheuer G, Seaman MS, Klein F, Caskey M, Nussenzweig MC. Combination therapy with anti-HIV-1 antibodies maintains viral suppression. Nature. 2018 Sep;561(7724):479-484. doi: 10.1038/s41586-018-0531-2. Epub 2018 Sep 26.
PubMed 30258136Niessl J, Baxter AE, Mendoza P, Jankovic M, Cohen YZ, Butler AL, Lu CL, Dube M, Shimeliovich I, Gruell H, Klein F, Caskey M, Nussenzweig MC, Kaufmann DE. Combination anti-HIV-1 antibody therapy is associated with increased virus-specific T cell immunity. Nat Med. 2020 Feb;26(2):222-227. doi: 10.1038/s41591-019-0747-1. Epub 2020 Feb 3.
PubMed 32015556Gaebler C, Nogueira L, Stoffel E, Oliveira TY, Breton G, Millard KG, Turroja M, Butler A, Ramos V, Seaman MS, Reeves JD, Petroupoulos CJ, Shimeliovich I, Gazumyan A, Jiang CS, Jilg N, Scheid JF, Gandhi R, Walker BD, Sneller MC, Fauci A, Chun TW, Caskey M, Nussenzweig MC. Prolonged viral suppression with anti-HIV-1 antibody therapy. Nature. 2022 Jun;606(7913):368-374. doi: 10.1038/s41586-022-04597-1. Epub 2022 Apr 13.
PubMed 35418681
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT05612178
- Acronym / sponsor ID
- 10001037
- Conditions
- HIV-1
- Keywords
- bNAb, HIV Reservoir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Nov 2022 (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.
Background:
Antiretroviral therapy (ART) can suppress HIV to undetectable levels in people, but the virus rebounds quickly if the drug treatment is stopped; this is because HIV can remain dormant in a pool of blood cells called the persistent viral reservoir (PVR). Yet lifelong ART is expensive and can lead to serious side effects over the long term. Some drugs may be more effective at reducing the PVR.
Objective:
To see if 2 study drugs (3BNC117-LS and 10-1074-LS) are safe and if they can lower the number of HIV-infected blood cells in people with HIV who are on ART.
Eligibility:
People aged 18 to 70 years with HIV who are on ART.
Design:
Participants will be screened. They will have a physical exam and blood and urine tests. They will undergo leukapheresis. Leukapheresis is a procedure where blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm.
The study drugs or placebo (normal saline) will be administered 3 times at 20-week intervals. The drugs will be given through a tube attached to a needle inserted into a vein in the arm. This will take 1 hour. Some participants will receive only a saline solution. They will not know if they are getting the drugs or the placebo.
Participants will undergo leukapheresis up to 4 more times during the study.
Participants will have follow-up visits every 10 weeks until the study ends.
Detailed description
Study Description:
This is randomized placebo-controlled study of the safety and virologic activity of the 3BNC117-LS plus 10-1074-LS broadly neutralizing antibody (bNAb) combination during standard antiretroviral therapy (ART).
Participants will be enrolled sequentially and randomized to receive 3BNC117-LS plus 10-1074-LS or placebo (sterile saline) at a 1:1 ratio. Participants will receive two intravenous infusions of 3BNC117-LS (dosed at 30 mg/kg) and 10-1074-LS (dosed at 10 mg/kg) or placebo at weeks 0 and 20. Participants will remain on ART during the study.
Objectives:
Primary Objectives:
-To evaluate the safety and tolerability of repeated doses of 3BNC117-LS and 10-1074-LS in adults living with human immunodeficiency virus (HIV) during suppressive ART.
Secondary Objectives:
- To evaluate the impact of 3BNC117-LS and 10-1074-LS on intact human immunodeficiency type 1 (HIV-1) proviruses over time in adults living with HIV during suppressive ART.
- To determine the effects of repeated doses of 3BNC117-LS and 10- 1074-LS during suppressive ART on HIV-1 specific cellular immune responses by enzyme-linked immunosorbent spot (ELISpot).
- To describe the pharmacokinetic parameters of the repeated doses of 3BNC117-LS and 10-1074-LS in adults living with HIV during suppressive ART.
Exploratory Objectives:
- To characterize the HIV-1 reservoir in peripheral blood during and following repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
- To evaluate effects on HIV-1 transcriptional activity during and following repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
- To characterize host HIV-1 specific humoral, cellular and innate immune responses during and following repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
- To correlate HIV-1 specific immune responses and effects on intact proviruses.
- To correlate virologic outcomes with bNAb sensitivity of reservoir proviruses.
Endpoints:<TAB>
Primary Endpoints:
-The occurrence of solicited and unsolicited grade 3 or higher adverse events (AE) (including confirmed laboratory abnormalities) that are possibly, probably, or definitely related to 3BNC117-LS and/or 10- 1074-LS, or premature study treatment discontinuation due to an AE (regardless of grade).
Secondary Endpoints:
- The occurrence of serious adverse events, regardless of relationship to 3BNC117-LS and/or 10-1074-LS.
- Change in the intact proviral reservoir size, measured by quadruplex polymerase chain reaction (Q4PCR) and/or intact proviral deoxyribonucleic acid assay (IPDA), from baseline to weeks 40 and 80 after dosing with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Changes in HIV-1 specific T cell immune responses in peripheral blood, measured by ELISpot, before, during and after dosing with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Pharmacokinetic parameters (including: peak concentrations, half- life, area under curve and clearance rate) of repeated doses of 3BNC117-LS and 10-1074-LS during suppressive ART.
Exploratory Endpoints:
- Size of the latent HIV-1 reservoir, measured by quantitative viral outgrowth assay (QVOA) and/or other appropriate assays, before, during and after dosing with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Composition of the intact proviral reservoir before and after immunotherapy with 3BNC117-LS and 10-1074-LS during suppressive ART by Q4PCR or other appropriate assays that may become available.
- The half-life of the HIV-1 intact proviral reservoir during 3BNC117- LS and 10-1074-LS therapy and ART suppression.
- HIV-1 transcriptional activity as determined by spliced and unspliced HIV-1 ribonucleic acid (RNA) in circulating total CD4+ T cells and/or other appropriate assays, before, during and after dosing with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Changes in HIV-1 specific T cell immune responses in peripheral blood, measured by assays such as polyfunctional intracellular cytokine staining (ICS) and viral inhibition assay before, during and after immunotherapy with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Changes in antibody dependent cell-mediated cytotoxicity (ADCC) against HIV-1-infected CD4+ T-cells by ex vivo autologous natural killer cells before and after immunotherapy with 3BNC117-LS and 10-1074-LS during suppressive ART.
- Correlation between magnitude, breadth and functionality of HIV-1 specific T cell immune responses and effects on intact proviruses.
- Correlation between changes in intact proviruses and bNAb sensitivity of reservoir proviruses determined by Env sequencing.
- Correlation between HIV-1 transcriptional activity and changes in the composition of the intact proviral reservoir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3BNC117-LS and 10-1074-LS | Experimental | Biological: 3BNC117-LS, Biological: 10-1074-LSParticipants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10-1074-LS (dosed at 10 mg/kg) at weeks 0, 20 and 40. |
| Placebo | Placebo comparator | Other: Sterile SalineParticipants will receive three intravenous infusions of placebo (Sterile Saline) at weeks 0, 20 and 40. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability to provide informed consent;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Adult persons of any sex or gender, aged 18 years to 70;
- Confirmed HIV-1 infection and clinically stable;
Key exclusion criteria (21 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- History of AIDS-defining illness within 3 years prior to enrollment;
- History of systemic corticosteroids (e.g., an equivalent dose of prednisone of > 20 mg daily for >14 days), 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 (e.g. such as autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), 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. NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible;
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-LSParticipants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10-1074-LS (dosed at 10 mg/kg) or placebo at weeks 0, 20 and 40. | Biological | 3BNC117-LS and 10-1074-LS |
| 10-1074-LSParticipants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10- 1074-LS (dosed at 10 mg/kg) or placebo at weeks 0, 20 and 40. | Biological | 3BNC117-LS and 10-1074-LS |
| Sterile SalineParticipants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10-1074-LS (dosed at 10 mg/kg) or placebo at weeks, 20 and 40. | Other | Placebo |
Primary outcome
Solicited and unsolicited grade 3 or higher adverse events
Time frame: Week 0 to End of Study
The occurrence of solicited and unsolicited grade 3 or higher adverse events (AE) (including confirmed laboratory abnormalities) that are possibly, probably, or definitely related to 3BNC117-LS and/or 10-1074-LS, or premature study treatment discontinuation due to an AE (regardless of grade).
4 secondary outcomes
Occurrence of Serious Adverse Events
Time frame: Week 0 to End of Study
Change in the intact proviral reservoir size
Time frame: Baseline to Weeks 40 and 80
Changes in HIV-1 specific T cell immune responses in peripheral blood
Time frame: Throughout
Pharmacokinetic parameters
Time frame: Throughout
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 1 Oct 2026.
- Background: PubMed 30258136Mendoza P, Gruell H, Nogueira L, Pai JA, Butler AL, Millard K, Lehmann C, Suarez I, Oliveira TY, Lorenzi JCC, Cohen YZ, Wyen C, Kummerle T, Karagounis T, Lu CL, Handl L, Unson-O'Brien C, Patel R, Ruping C, Schlotz M, Witmer-Pack M, Shimeliovich I, Kremer G, Thomas E, Seaton KE, Horowitz J, West AP Jr, Bjorkman PJ, Tomaras GD, Gulick RM, Pfeifer N, Fatkenheuer G, Seaman MS, Klein F, Caskey M, Nussenzweig MC. Combination therapy with anti-HIV-1 antibodies maintains viral suppression. Nature. 2018 Sep;561(7724):479-484. doi: 10.1038/s41586-018-0531-2. Epub 2018 Sep 26.
- Background: PubMed 32015556Niessl J, Baxter AE, Mendoza P, Jankovic M, Cohen YZ, Butler AL, Lu CL, Dube M, Shimeliovich I, Gruell H, Klein F, Caskey M, Nussenzweig MC, Kaufmann DE. Combination anti-HIV-1 antibody therapy is associated with increased virus-specific T cell immunity. Nat Med. 2020 Feb;26(2):222-227. doi: 10.1038/s41591-019-0747-1. Epub 2020 Feb 3.
- Background: PubMed 35418681Gaebler C, Nogueira L, Stoffel E, Oliveira TY, Breton G, Millard KG, Turroja M, Butler A, Ramos V, Seaman MS, Reeves JD, Petroupoulos CJ, Shimeliovich I, Gazumyan A, Jiang CS, Jilg N, Scheid JF, Gandhi R, Walker BD, Sneller MC, Fauci A, Chun TW, Caskey M, Nussenzweig MC. Prolonged viral suppression with anti-HIV-1 antibody therapy. Nature. 2022 Jun;606(7913):368-374. doi: 10.1038/s41586-022-04597-1. Epub 2022 Apr 13.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Michael C Sneller, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3BNC117-LS, 10-1074-LS and Sterile Saline in people with HIV-1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
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 17 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited and unsolicited grade 3 or higher adverse events (time frame: Week 0 to End of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612178, which also lists 3 linked publications.
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 1 Oct 2026.