Human Immunodeficiency VirusPhase 1NCT03526848
3BNC117 and 10-1074 in ART-treated Individuals
A Phase 1 study testing 3BNC117, 10-1074 and Analytical treatment interruption in people with Human Immunodeficiency Virus, run by Rockefeller University at 2 sites in United States.
Trial summary
The proposed study is a phase 1, open label, randomized study to evaluate the safety and antiretroviral activity of seven infusions of 3BNC117 and 10-1074, administered intravenously at 30 mg/kg dose level, in human immunodeficiency virus (HIV)-infected individuals on combination antiretroviral therapy (ART) and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- 3BNC117, 10-1074 and Analytical treatment interruption
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2018to 11 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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:
Show all 24Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ragon Institute of MGH, MIT, and Harvard
Boston, Massachusetts, 02114
The Rockefeller University
New York, New York, 10065
About this study
Official title: An Open Label, Randomized Study of the Safety and Antiretroviral Activity of 3BNC117 and 10-1074 in HIV-infected Individuals on Combination Antiretroviral Therapy and During Analytical Treatment Interruption.
The proposed study is a phase 1, open label, randomized study to evaluate the safety and antiretroviral activity of seven infusions of 3BNC117 and 10-1074, administered intravenously at 30 mg/kg dose level, in human immunodeficiency virus (HIV)-infected individuals on combination antiretroviral therapy (ART) and during an analytical interruption of ART.
Read the detailed description
The proposed study is an open label study of the safety and antiretroviral activity of 3BNC117 and 10-1074 in HIV-infected individuals with well-controlled HIV infection on combination antiretroviral therapy (ART). 3BNC117 and 10-1074 are two broadly neutralizing antibodies (bNAbs) that target different sites on HIV-1 gp120. Our hypothesis is that the administration of repeated infusions of 3BNC117 and 10-1074 in the absence of ART will be safe and well tolerated, will maintain viral suppression in HIV-infected individuals during analytical treatment interruption (ATI) and will interfere with the maintenance of the HIV-1 reservoir.
Forty eligible participants will be randomized to either Group 1 or Group 2 in a 3:1 ratio:
Group 1 (n=30): participants will discontinue ART 2 days after the first infusion of 3BNC117 and 10-1074, and will receive 6 additional infusions of both antibodies at weeks 2, 4, 8, 12, 16 and 20 (Part A). Participants will remain off ART until week 38, if viral suppression is maintained (Part B).
Group 2 (n=10): participants will remain on ART and will be administered seven infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16 and 20 (Part A). ART will be discontinued at week 26 until week 38, if viral suppression is maintained (Part B).
After screening, participants will remain on ART and undergo leukapheresis, and will have the option to undergo LN biopsies 2-4 weeks prior to first 3BNC117 and 10-1074 infusions.
Participants enrolled in group 1 will discontinue their ART 2 days after the first 3BNC117 and 10-1074 infusions. Participants enrolled in group 2 will discontinue their ART at week 26. If the participant's ART regimen includes an NNRTI, the NNRTI will be switched to an integrase inhibitor-based regimen, 4 weeks prior discontinuing all antiretroviral drugs.
During the ATI periods of the study, ART will be resumed if there is a > 30% decline in CD4+ T cell count or CD4+ T cell count decreases to < 350 cells/μl from baseline (day 0) and these changes are confirmed during next visit. ART will also be re-initiated if the participant develops symptoms of severe acute retroviral syndrome or becomes pregnant. In addition, ART will be resumed according the following virologic parameters:
Part A (wk 0 - wk 26), ART will be resumed if group 1 participants have 2 consecutive plasma HIV-1 RNA levels > 200 copies/ml.
Part B (wk 26 - wk 38), ART will be resumed if group 1 or group 2 participants have sustained (> 4 weeks) HIV-1 RNA levels > 1,000 copies/ml.
Part C (wk 38 - wk 48), group 1 and group 2 participants who have not met criteria to reinitiate ART will be offered to continue off ART with close monitoring. In Part C, ART will be resumed if the participant has 2 consecutive plasma HIV-1 RNA levels > 1,000 copies/ml.
All participants will be followed for a total of 48 weeks from enrollment (day 0). Participants will be invited to return for a large blood draw after they reach at least 24 weeks of viral suppression after ART is re-initiated, if this occurs after the active study follow up period.
Safety assessments will be performed at multiple time points following 3BNC117 and 10-1074 infusions. The effects of 3BNC117 and 10-1074 infusions on the HIV-1 reservoir of ART-suppressed HIV-infected individuals will be evaluated by several assays. These evaluations will occur at baseline (day 0) and at week 26.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- 3BNC117, 10-1074, Analytical treatment interruption
- Keywords
- 3BNC117, 10-1074, Broadly Neutralizing Antibody
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3BNC117Drug
Also called Monoclonal antibody
Intravenous infusion of 3BNC117
10-1074Drug
Also called Monoclonal antibody
Intravenous infusion of 3BNC117
Analytical treatment interruptionOther
Also called ART interruption
Analytical treatment interruption
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | HIV infected participants on ART will undergo analytical treatment interruption 2 days after the first infusion of 3BNC117 and 10-1074, and will receive 6 additional infusions of both antibodies at weeks 2, 4, 8, 12, 16 and 20 (Part A). Participants will remain off ART until week 38, if viral suppression is maintained (Part B). Receives: Drug: 3BNC117; Drug: 10-1074; Other: Analytical treatment interruption |
| Group 2 | Experimental | HIV infected participants on ART will remain on ART and will be administered seven infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16 and 20 (Part A). Analytical treatment interruption will begin at week 26 until week 38, if viral suppression is maintained (Part B). Receives: Drug: 3BNC117; Drug: 10-1074; Other: Analytical treatment interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the size of the functional, latent HIV-1 reservoir between baseline and after seven infusions of 3BNC117 and 10-1074
The size of the functional, latent HIV-1 reservoir is determined by the number of infectious units per 106 resting memory CD4+ T cells (IUPM) using a viral outgrowth assay at baseline and after seven infusions of 3BNC117 and 10-1074
Measured: Day 0 and week 26
The size of the proviral HIV-1 reservoir
Size of the proviral HIV-1 reservoir as determined by total HIV-1 DNA and integrated HIV-1 DNA in circulating total CD4+ T cells before and after seven infusions of 3BNC117 and 10-1074.
Measured: 48 weeks
The rate of viral rebound
Rate of viral rebound (plasma HIV-1 RNA level > 200 copies/ml in 2 consecutive measurements) or indication to reinitiate ART at 12 weeks after ART interruption (study week 12 in group 1, study week 38 in group 2).
Measured: Week 12 (group 1) and week 38 (group 2)
Time to return of HIV-1 viremia
Time to return of HIV-1 viremia (plasma HIV-1 RNA level > 200 copies/ml in 2 consecutive measurements) after ART interruption.
Measured: 48 weeks
The rate of adverse events (AE) and serious adverse events (SAE).
The rate of adverse events (AE) and serious adverse events (SAE).
Measured: 48 weeks
The severity of adverse events (AE) and serious adverse events (SAE).
The severity of adverse events (AE) and serious adverse events (SAE).
Measured: 48 weeks
Secondary outcomes (2)
The rate of viral rebound at 26 weeks after ART interruption in group 1.
Rate of viral rebound (plasma HIV-1 RNA level > 200 copies/ml in 2 consecutive measurements) at 26 weeks after ART interruption in group 1.
Measured: 26 weeks
Serum levels of 3BNC117 and 10-1074 at the time of viral rebound
Serum levels of 3BNC117 and 10-1074 at the time of viral rebound
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start5 Jun 2018
- Primary completion30 Sep 2021
- Study completion11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Ragon Institute of MGH, MIT and Harvard, Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Marina Caskey, MD, Study chair, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526848
- Sponsor's protocol ID
- MCA-0965
- Status last verified
- Sep 2025
- First submitted
- 3 May 2018
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Study of the Safety and Antiretroviral Activity of 3BNC117 and 10-1074 in HIV-infected Individuals on Combination Antiretroviral Therapy and During Analytical Treatment Interruption.
- ClinicalTrials.gov ID
- NCT03526848
- Acronym / sponsor ID
- MCA-0965
- Conditions
- Human Immunodeficiency Virus
- Keywords
- 3BNC117, 10-1074, Broadly Neutralizing Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Ragon Institute of MGH, MIT and Harvard, Montefiore Medical Center
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 16 May 2018 (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.
The proposed study is a phase 1, open label, randomized study to evaluate the safety and antiretroviral activity of seven infusions of 3BNC117 and 10-1074, administered intravenously at 30 mg/kg dose level, in human immunodeficiency virus (HIV)-infected individuals on combination antiretroviral therapy (ART) and during an analytical interruption of ART.
Detailed description
The proposed study is an open label study of the safety and antiretroviral activity of 3BNC117 and 10-1074 in HIV-infected individuals with well-controlled HIV infection on combination antiretroviral therapy (ART). 3BNC117 and 10-1074 are two broadly neutralizing antibodies (bNAbs) that target different sites on HIV-1 gp120. Our hypothesis is that the administration of repeated infusions of 3BNC117 and 10-1074 in the absence of ART will be safe and well tolerated, will maintain viral suppression in HIV-infected individuals during analytical treatment interruption (ATI) and will interfere with the maintenance of the HIV-1 reservoir.
Forty eligible participants will be randomized to either Group 1 or Group 2 in a 3:1 ratio:
Group 1 (n=30): participants will discontinue ART 2 days after the first infusion of 3BNC117 and 10-1074, and will receive 6 additional infusions of both antibodies at weeks 2, 4, 8, 12, 16 and 20 (Part A). Participants will remain off ART until week 38, if viral suppression is maintained (Part B).
Group 2 (n=10): participants will remain on ART and will be administered seven infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16 and 20 (Part A). ART will be discontinued at week 26 until week 38, if viral suppression is maintained (Part B).
After screening, participants will remain on ART and undergo leukapheresis, and will have the option to undergo LN biopsies 2-4 weeks prior to first 3BNC117 and 10-1074 infusions.
Participants enrolled in group 1 will discontinue their ART 2 days after the first 3BNC117 and 10-1074 infusions. Participants enrolled in group 2 will discontinue their ART at week 26. If the participant's ART regimen includes an NNRTI, the NNRTI will be switched to an integrase inhibitor-based regimen, 4 weeks prior discontinuing all antiretroviral drugs.
During the ATI periods of the study, ART will be resumed if there is a > 30% decline in CD4+ T cell count or CD4+ T cell count decreases to < 350 cells/μl from baseline (day 0) and these changes are confirmed during next visit. ART will also be re-initiated if the participant develops symptoms of severe acute retroviral syndrome or becomes pregnant. In addition, ART will be resumed according the following virologic parameters:
Part A (wk 0 - wk 26), ART will be resumed if group 1 participants have 2 consecutive plasma HIV-1 RNA levels > 200 copies/ml.
Part B (wk 26 - wk 38), ART will be resumed if group 1 or group 2 participants have sustained (> 4 weeks) HIV-1 RNA levels > 1,000 copies/ml.
Part C (wk 38 - wk 48), group 1 and group 2 participants who have not met criteria to reinitiate ART will be offered to continue off ART with close monitoring. In Part C, ART will be resumed if the participant has 2 consecutive plasma HIV-1 RNA levels > 1,000 copies/ml.
All participants will be followed for a total of 48 weeks from enrollment (day 0). Participants will be invited to return for a large blood draw after they reach at least 24 weeks of viral suppression after ART is re-initiated, if this occurs after the active study follow up period.
Safety assessments will be performed at multiple time points following 3BNC117 and 10-1074 infusions. The effects of 3BNC117 and 10-1074 infusions on the HIV-1 reservoir of ART-suppressed HIV-infected individuals will be evaluated by several assays. These evaluations will occur at baseline (day 0) and at week 26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: 3BNC117, Drug: 10-1074, Other: Analytical treatment interruptionHIV infected participants on ART will undergo analytical treatment interruption 2 days after the first infusion of 3BNC117 and 10-1074, and will receive 6 additional infusions of both antibodies at weeks 2, 4, 8, 12, 16 and 20 (Part A). Participants will remain off ART until week 38, if viral suppression is maintained (Part B). |
| Group 2 | Experimental | Drug: 3BNC117, Drug: 10-1074, Other: Analytical treatment interruptionHIV infected participants on ART will remain on ART and will be administered seven infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16 and 20 (Part A). Analytical treatment interruption will begin at week 26 until week 38, if viral suppression is maintained (Part B). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| 3BNC117Also: Monoclonal antibodyIntravenous infusion of 3BNC117 | Drug | Group 1, Group 2 |
| 10-1074Also: Monoclonal antibodyIntravenous infusion of 3BNC117 | Drug | Group 1, Group 2 |
| Analytical treatment interruptionAlso: ART interruptionAnalytical treatment interruption | Other | Group 1, Group 2 |
Primary outcome
The change in the size of the functional, latent HIV-1 reservoir between baseline and after seven infusions of 3BNC117 and 10-1074
Time frame: Day 0 and week 26
The size of the functional, latent HIV-1 reservoir is determined by the number of infectious units per 106 resting memory CD4+ T cells (IUPM) using a viral outgrowth assay at baseline and after seven infusions of 3BNC117 and 10-1074
The size of the proviral HIV-1 reservoir
Time frame: 48 weeks
Size of the proviral HIV-1 reservoir as determined by total HIV-1 DNA and integrated HIV-1 DNA in circulating total CD4+ T cells before and after seven infusions of 3BNC117 and 10-1074.
The rate of viral rebound
Time frame: Week 12 (group 1) and week 38 (group 2)
Rate of viral rebound (plasma HIV-1 RNA level > 200 copies/ml in 2 consecutive measurements) or indication to reinitiate ART at 12 weeks after ART interruption (study week 12 in group 1, study week 38 in group 2).
Time to return of HIV-1 viremia
Time frame: 48 weeks
Time to return of HIV-1 viremia (plasma HIV-1 RNA level > 200 copies/ml in 2 consecutive measurements) after ART interruption.
The rate of adverse events (AE) and serious adverse events (SAE).
Time frame: 48 weeks
The rate of adverse events (AE) and serious adverse events (SAE).
The severity of adverse events (AE) and serious adverse events (SAE).
Time frame: 48 weeks
The severity of adverse events (AE) and serious adverse events (SAE).
2 secondary outcomes
The rate of viral rebound at 26 weeks after ART interruption in group 1.
Time frame: 26 weeks
Serum levels of 3BNC117 and 10-1074 at the time of viral rebound
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- 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. This study is not recruiting at the moment.
Marina Caskey, MD study chair
The Rockefeller University
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, 10-1074 and Analytical treatment interruption in people with Human Immunodeficiency Virus, run by Rockefeller University 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 6 inclusion and 24 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: finished, as of the sponsor's last update on 1 Oct 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in the size of the functional, latent HIV-1 reservoir between baseline and after seven infusions of 3BNC117 and 10-1074 (time frame: Day 0 and week 26). The study lists 6 primary outcomes in all. 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 1 Oct 2025.