Human Immunodeficiency VirusPhase 1NCT03254277

3BNC117-LS First-in-Human Phase 1 Study

A Phase 1 study testing 3BNC117-LS in people with Human Immunodeficiency Virus, run by Rockefeller University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The proposed study is a phase 1 study of the mAb 3BNC117-LS administered intravenously in HIV uninfected individuals and HIV-infected individuals, and subcutaneously in HIV-uninfected individuals.The objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of a single administration of… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: 3BNC117-LS
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 13 Sep 2017to 31 Dec 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Groups 1A-1F (HIV-uninfected):
Males and females, age 18 to 65
Amenable to HIV risk reduction counseling and agrees to maintain behavior consistent with low risk of HIV exposure.
If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) from 10 days prior to and until seven months after 3BNC117-LS infusion, and agrees to safer sex counseling at each visit.
Female study participants of reproductive potential are defined as pre-menopausal women who have not had a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy). Women are considered menopausal if they have not had a menses for at least 12 months and have a FSH of greater than 40 IU/L or if FSH testing is not available, they have had amenorrhea for 24 consecutive months.
Groups 2B-2D (HIV-infected):

Show all 11Show fewer

Males and females, age 18 to 65.
HIV-1 infection confirmed by two laboratory assays.
HIV-infected individuals off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml by standard assays (ART-naïve or off ART due to intolerance or by choice), or on ART with HIV-1 plasma RNA levels < 20 copies/ml. HIV-1 RNA levels should be measured on 2 occasions, at least 1 week apart. At least one measurement must be performed within 49 days prior to enrollment (day 0). Group 2D will only enroll HIV-infected individuals on ART.
Current CD4+ T cell count > 300 cells/μl.
If sexually active male or female, and participating in sexual activity that could lead to pregnancy or transmission of HIV, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) from 10 days prior to and until seven months after 3BNC117-LS infusion, and agrees to safer sex counseling at each visit.

Who cannot join

Groups 1A-1F (HIV-uninfected):
Confirmed HIV-1 or HIV-2 infection.
History of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive anti-cancer, 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) that in the opinion of the investigator would preclude participation.
Within the 12 months prior to enrollment, the participant has a history of sexually transmitted infection.
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.

Show all 41Show fewer

Laboratory abnormalities in the parameters listed:
Absolute neutrophil count ≤ 1,500 cells/µL;
Hemoglobin ≤ 11 gm/dL if female; ≤ 12.5 gm/dL if male;
Platelet count ≤ 125,000 cells/µL;
Alanine transaminase (ALT) ≥ 1.25 x ULN;
Aspartate transaminase (AST) ≥ 1.25 x ULN;
Alkaline phosphatase ≥ 1.5 x ULN;
Total bilirubin > 1 x ULN;
Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
Pregnancy or lactation.
Any vaccination within 14 days prior to 3BNC117-LS infusion.
Receipt of any experimental HIV vaccine or monoclonal antibody therapy of any kind in the past.
History of severe reaction to a vaccine or drug infusion or history of severe allergic reactions.
Individuals with known hypersensitivity to any constituent of the investigational product.
Receipt of another investigational product currently or within the past 12 weeks, or expected concurrent participation in another study in which investigational products will be administered.
Groups 2B-2D (HIV-infected):
Have a history of AIDS-defining illness within 3 years prior to enrollment.
History of systemic corticosteroids, immunosuppressive anti-cancer, 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.
Laboratory abnormalities in the parameters listed below:
Absolute neutrophil count ≤ 1,000 cells/μl;
Hemoglobin ≤ 10 gm/dL;
Platelet count ≤ 100,000 cells/μl;
ALT ≥ 1.5 x ULN;
AST ≥ 1.5 x ULN;
Alkaline phosphatase ≥ 1.5 x ULN;
Total bilirubin > 1 x ULN;
eGFR < 60 mL/min/1.73m2.
Pregnancy or lactation.
Any vaccination within 14 days prior to 3BNC117-LS infusion.
Receipt of any experimental HIV vaccine or monoclonal antibody therapy of any kind in the past.
History of severe reaction to a vaccine or drug infusion or history of severe allergic reactions.
Individuals with known hypersensitivity to any constituent of the investigational product.
Receipt of another investigational product currently or within the past 12 weeks, or expected concurrent participation in another study in which investigational products will be administered.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Rockefeller University
New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 1 First-in-human Study of the Safety and Pharmacokinetics of 3BNC117-LS in HIV-infected and HIV-uninfected Individuals

Read the detailed description

The proposed study is a Phase 1, open label, dose escalation cohort study of 3BNC117-LS administered intravenously in HIV-uninfected and HIV-1 infected participants.

This study consists of two parts. In part A, study participants will be enrolled in an open label manner to receive a single intravenous infusion of 3BNC117-LS at one of three increasing dose levels (3 mg/kg, 10 mg/kg and 30 mg/kg). Participants in Part B will also receive a single administration of 3BNC117-LS, however, the product administered in Part B of the study derives from a new manufacturing lot. The manufacturing lot used in Part A had incomplete glycosylation of the 3BNC117-LS light chain, which has been corrected in the new lot. Participants in Part B will receive 3BNC117-LS intravenously at 30 mg/kg in an open label manner (HIV-uninfected and HIV-infected) or will be randomized to receive a subcutaneous injection of 3BNC117-LS or placebo in a double-blinded fashion (HIV-uninfected only).

Part A has already been enrolled with 21 participants. Part B has a planned enrollment of 22 participants.

Part A

Group 1A (n=3-6) - HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 3 mg/kg.
Group 1B (n=3-6) - HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
Group 1C (n=3-6) - HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 2B (n=6) - HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml or off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
Group 2C (n=6) - HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.

Part B

Group 1D (n=3) - HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 2D (n=3) - HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 1E (n=8) - HIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Group 1F (n=8) - HIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.

Following 3BNC117-LS infusion, study participants will return for safety assessments at weeks 1, 2 and 4 following infusion, then bi-monthly or monthly until the end of study follow up.

Serum samples for PK (pharmacokinetic) measurements will be collected before 3BNC117-LS infusion, at the end of the infusion, and at multiple time points during study follow up.

Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117-LS infusion (screen, pre-infusion and day 0) and at all follow up visits in Groups 2B and 2C.

All participants will be followed for 48 weeks after 3BNC117-LS administration.

Conditions: Human Immunodeficiency Virus
Being tested: 3BNC117-LS, Placebo
Keywords: Broadly Neutralizing Antibody, 3BNC117-LS, First in Human, Dose Escalation
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.

3BNC117-LSDrug
Also called Monoclonal Antibody
Intravenous infusion of 3BNC117-LS
PlaceboDrug
Placebo

Study groups in NCT03254277
Study group	Role	What they receive
Group 1A	Experimental	HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 3 mg/kg. Receives: Drug: 3BNC117-LS
Group 1B	Experimental	HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg. Receives: Drug: 3BNC117-LS
Group 1C	Experimental	HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg. Receives: Drug: 3BNC117-LS
Group 2B	Experimental	HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml or off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg. Receives: Drug: 3BNC117-LS
Group 2C	Experimental	HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg. Receives: Drug: 3BNC117-LS
Group 1D	Experimental	HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg. Receives: Drug: 3BNC117-LS
Group 2D	Experimental	HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg. Receives: Drug: 3BNC117-LS
Group 1E	Experimental	HIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio. Receives: Drug: 3BNC117-LS; Drug: Placebo
Group 1F	Experimental	HIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio. Receives: Drug: 3BNC117-LS; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Participants Who Experience Adverse Events Within 2 Weeks After 3BNC117-LS Infusion in All Study Groups
Adverse events include signs, symptoms and laboratory abnormalities, in addition to local and systemic reactogenicity adverse events.
Measured: 2 weeks following the 3BNC117-LS infusion
Elimination Half-life (t1/2) of 3BNC117-LS in All Study Groups
Elimination half-life (t1/2) measured in days of 3BNC117-LS in all study groups
Measured: 48 weeks

Secondary outcomes (2)

Frequency of Induced Anti-3BNC117-LS Antibodies in All Study Groups.
number of participants with induced Anti-3BNC117-LS antibodies in all study groups
Measured: 48 weeks
The Number of Participants Who Experience Adverse Events During Study Follow-up
Adverse events include signs, symptoms and laboratory abnormalities
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 201731 Dec 2020

First posted18 Aug 2017
Study start13 Sep 2017
Primary completion31 Dec 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03254277
Sponsor's protocol ID: YCO-0946
Status last verified: Apr 2026
First submitted: 11 Aug 2017
Last updated: 20 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Valente PK, Wu Y, Cohen YZ, Caskey M, Meyers K. Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention. Clin Trials. 2021 Feb;18(1):17-27. doi: 10.1177/1740774520948042. Epub 2020 Aug 24.
PubMed 32838558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 First-in-human Study of the Safety and Pharmacokinetics of 3BNC117-LS in HIV-infected and HIV-uninfected Individuals
ClinicalTrials.gov ID: NCT03254277
Acronym / sponsor ID: YCO-0946
Conditions: Human Immunodeficiency Virus
Keywords: Broadly Neutralizing Antibody, 3BNC117-LS, First in Human, Dose Escalation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Rockefeller UniversityUniversity, hospital or other
Study start: 13 Sep 2017 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 18 Aug 2017 (actual)
Results: Posted 20 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The proposed study is a Phase 1, open label, dose escalation cohort study of 3BNC117-LS administered intravenously in HIV-uninfected and HIV-1 infected participants.

Part A has already been enrolled with 21 participants. Part B has a planned enrollment of 22 participants.

Part A

Group 1A (n=3-6) - HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 3 mg/kg.
Group 1B (n=3-6) - HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
Group 1C (n=3-6) - HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 2B (n=6) - HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml or off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
Group 2C (n=6) - HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.

Part B

Group 1D (n=3) - HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 2D (n=3) - HIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 1E (n=8) - HIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Group 1F (n=8) - HIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.

Following 3BNC117-LS infusion, study participants will return for safety assessments at weeks 1, 2 and 4 following infusion, then bi-monthly or monthly until the end of study follow up.

Serum samples for PK (pharmacokinetic) measurements will be collected before 3BNC117-LS infusion, at the end of the infusion, and at multiple time points during study follow up.

Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117-LS infusion (screen, pre-infusion and day 0) and at all follow up visits in Groups 2B and 2C.

All participants will be followed for 48 weeks after 3BNC117-LS administration.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Group 1A	Experimental	Drug: 3BNC117-LSHIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 3 mg/kg.
Group 1B	Experimental	Drug: 3BNC117-LSHIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
Group 1C	Experimental	Drug: 3BNC117-LSHIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 2B	Experimental	Drug: 3BNC117-LSHIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml or off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
Group 2C	Experimental	Drug: 3BNC117-LSHIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 1D	Experimental	Drug: 3BNC117-LSHIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 2D	Experimental	Drug: 3BNC117-LSHIV-infected individuals on ART with HIV-1 plasma RNA levels < 20 copies/ml will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Group 1E	Experimental	Drug: 3BNC117-LS, Drug: PlaceboHIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Group 1F	Experimental	Drug: 3BNC117-LS, Drug: PlaceboHIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Males and females, age 18 to 65
Amenable to HIV risk reduction counseling and agrees to maintain behavior consistent with low risk of HIV exposure.
If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) from 10 days prior to and until seven months after 3BNC117-LS infusion, and agrees to safer sex counseling at each visit.
Males and females, age 18 to 65.
HIV-1 infection confirmed by two laboratory assays.

Key exclusion criteria (41 listed)

Confirmed HIV-1 or HIV-2 infection.
History of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive anti-cancer, 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) that in the opinion of the investigator would preclude participation.
Within the 12 months prior to enrollment, the participant has a history of sexually transmitted infection.
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.

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-LSAlso: Monoclonal AntibodyIntravenous infusion of 3BNC117-LS	Drug	Group 1A, Group 1B, Group 1C, Group 1D, Group 1E, Group 1F, Group 2B, Group 2C, Group 2D
PlaceboPlacebo	Drug	Group 1E, Group 1F

Primary outcome

The Number of Participants Who Experience Adverse Events Within 2 Weeks After 3BNC117-LS Infusion in All Study Groups
Time frame: 2 weeks following the 3BNC117-LS infusion
Adverse events include signs, symptoms and laboratory abnormalities, in addition to local and systemic reactogenicity adverse events.
Elimination Half-life (t1/2) of 3BNC117-LS in All Study Groups
Time frame: 48 weeks
Elimination half-life (t1/2) measured in days of 3BNC117-LS in all study groups

2 secondary outcomes

Frequency of Induced Anti-3BNC117-LS Antibodies in All Study Groups.
Time frame: 48 weeks
The Number of Participants Who Experience Adverse Events During Study Follow-up
Time frame: 48 weeks

Results and safety

Results posted to the registry on 20 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1A	3	3
Group 1B	3	3
Group 1C	6	5
Group 2B	3	3
Group 2C	6	6
Group 1D	3	2
Group 2D	3	3
Group 1E 3BNC117-LS	6	6
Group 1F 3BNC117-LS	6	6
Group 1E Placebo	2	2
Group 1F Placebo	2	0

Primary outcome: The Number of Participants Who Experience Adverse Events Within 2 Weeks After 3BNC117-LS Infusion in All Study Groups

Time frame: 2 weeks following the 3BNC117-LS infusion. Count of participants. Unit: Participants

Measure	Group 1A n = 3	Group 1B n = 3	Group 1C n = 6	Group 2B n = 3	Group 2C n = 6	Group 1D n = 3	Group 2D n = 3	Group 1E 3BNC117-LS n = 6	Groups 1F 3BNC117-LS n = 6	Group 1E Placebo n = 2	Group 1F Placebo n = 2
Value	0	0	1	0	1	0	0	1	1	1	0

Population analysed: All participants who received the investigational product

Primary outcome: Elimination Half-life (t1/2) of 3BNC117-LS in All Study Groups

Time frame: 48 weeks. Median (Full Range). Unit: Days (median half-life per group)

Measure	Group 1A n = 3	Group 1B n = 3	Group 1C n = 6	Group 2B n = 3	Group 2C n = 6	Group 1D n = 3	Group 2D n = 3	Group 1E- 3BNC117-LS n = 6	Group 1F - 3BNC117-LS n = 6
Value	76.33 (69.31 to 107.30)	58.81 (51.48 to 59.00)	61.98 (41.49 to 83.51)	60.83 (54.10 to 98.85)	45.45 (41.85 to 62.64)	59.04 (57.60 to 64.41)	52.44 (39.49 to 64.52)	63.60 (53.82 to 76.65)	67.59 (49.69 to 78.26)

Population analysed: Groups 1E placebo and 1F placebo were not analyzed as they did not received the investigational product

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1A	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Group 1B	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Group 1C	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Group 2B	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Group 2C	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Group 1D	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Group 2D	1 of 3 (33.3%)	1 of 3 (33.3%)	0 of 3
Group 1E 3BNC117-LS	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Group 1F 3BNC117-LS	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6
Group 1E Placebo	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Group 1F Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32838558Valente PK, Wu Y, Cohen YZ, Caskey M, Meyers K. Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention. Clin Trials. 2021 Feb;18(1):17-27. doi: 10.1177/1740774520948042. Epub 2020 Aug 24.
Individual participant dataSharing planned: No

Related trials for Human Immunodeficiency Virus

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

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 principal investigator

The Rockefeller University

1 site 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 in people with Human Immunodeficiency Virus, run by Rockefeller University at 1 site 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 11 inclusion and 41 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Number of Participants Who Experience Adverse Events Within 2 Weeks After 3BNC117-LS Infusion in All Study Groups (time frame: 2 weeks following the 3BNC117-LS infusion). The study lists 2 primary outcomes in all. 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 NCT03254277, which also lists 1 linked publication.

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 20 May 2026.