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AzTrials

HIV-1-infectionPhase 1/2NCT04173819

Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults

A Phase 1/2 study testing 3BNC117-LS-J, 10-1074-LS-J and Combination 3BNC117-LS-J and 10-1074-LS-J in people with HIV-1-infection, run by International AIDS Vaccine Initiative at 9 sites in 5 countries.

Completed

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

Official record
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Trial summary

This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
HIV-1-infection
What is being tested?
3BNC117-LS-J, 10-1074-LS-J and Combination 3BNC117-LS-J and 10-1074-LS-J
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
225 participants
Where
9 sitesin 5 countries
Study dates
18 Feb 2020to 1 Sep 2023
Phase
Phase 1/2
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and female individuals, as assessed by a medical history, physical exam, and laboratory tests
  • At least 18 years of age on the day of screening and have not reached their 46th birthday on the day of the first administration
  • Willing to undergo HIV testing, risk reduction counseling and receive HIV test results; committed to maintaining low-risk behavior for the trial duration
  • Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
  • All male and female participants of reproductive potential who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from enrollment until 9 months after the last administration
  • Willing to forgo donations of blood, or any other tissues during the study following confirmation of study eligibility and, for those who test HIV-positive due to antibody-induced seropositivity, until the anti-HIV antibody titers become undetectable on HIV tests used in the community

Who cannot join

  • Confirmed HIV infection
  • Reported risk for HIV infection within 6 months prior to investigational product administration, as defined by: Unprotected sexual intercourse with a known HIV-infected person, a partner known to be at high risk for HIV infection and/or a casual partner (i.e. no continuing established relationship), engaged in sex work, frequent excessive daily alcohol use or frequent binge drinking or any other use of illicit drugs, history of newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV-2, chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B or hepatitis C, three or more sexual partners
  • Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study
  • Infectious disease diagnosis: Hepatitis B infection as measured by HbsAg and/or PCR, Hepatitis C infection (US: HCV RNA positive, or interferon-alpha treatment for hepatitis C infection in the past year, or interferon-alpha-free treatment for hepatitis C infection completed in the past 6 months; Africa: HCV Ab positive and/or PCR positive), active syphilis (positive RPR confirmed by TPHA)
  • Receipt of blood transfusion or blood-derived products within the previous 3 months
  • Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study (Concurrent participation in an observational trial not requiring blood or tissue sample collection is not an exclusion)
Show all 9Show fewer
  • Psychiatric condition that compromises safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
  • Body mass index (BMI) >40
  • Active tuberculosis

Trial locations and contacts

9 sites in 5 countries.

9 sites in 5 countries

United States3 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • The Rockefeller University

    New York, New York, 10065

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

Kenya2 sites

  • Kenya AIDS Vaccine Initiative - Institute of Clinical Research

    Nairobi

  • Partners in Health Research and Development

    Thika, Kiambu County

Other trials in Kenya

Uganda2 sites

  • Uganda Virus Research Institute

    Entebbe

  • Infectious Diseases Institute Kasangati

    Kampala

Other trials in Uganda

Rwanda1 site

  • Center for Family Health Research

    Kigali

Other trials in Rwanda

South Africa1 site

  • Wits Reproductive Health and HIV Institute

    Johannesburg

Other trials in South Africa

About this study

This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy HIV-1 uninfected adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain serum levels >10 µg/ml for at least 3 months in HIV-uninfected participants.

Conditions
HIV-1-infection
Being tested
3BNC117-LS-J, 10-1074-LS-J, Combination 3BNC117-LS-J and 10-1074-LS-J, Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1, Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3BNC117-LS-JBiological

    300mg

  • 10-1074-LS-JBiological

    300mg

  • Combination 3BNC117-LS-J and 10-1074-LS-JBiological

    30mg/kg of each

  • Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1Biological

    Total ~300 mg (< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2

  • Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2Biological

    Total ~300 mg (< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2

  • Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 3Biological

    Total ~300 mg (< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2

  • PlaceboBiological

    0.9% Saline

  • PlaceboBiological

    Buffer Solution

Study groups in NCT04173819
Study groupRoleWhat they receive
Group 1ExperimentalSingle Agent, abdominal subcutaneous injection, 10:2 ratio for Ab:placebo
Receives: Biological: 3BNC117-LS-J; Biological: Placebo
Group 2ExperimentalSingle agent, abdominal subcutaneous injection 10:2 ratio for Ab:placebo
Receives: Biological: 10-1074-LS-J; Biological: Placebo
Group 3ExperimentalSingle agent intravenous injection 10:2 ratio for Ab:placebo
Receives: Biological: 3BNC117-LS-J; Biological: Placebo
Group 4ExperimentalSingle agent intravenous injection 10:2 ratio for Ab:placebo
Receives: Biological: 10-1074-LS-J; Biological: Placebo
Group 5ExperimentalCombined agent intravenous injection 10:2 ratio for Ab:placebo
Receives: Biological: Combination 3BNC117-LS-J and 10-1074-LS-J; Biological: Placebo
Group 6ExperimentalSubcutaneous injection combined ratio 1 with loading dose 30:3 ratio of Ab:Placebo
Receives: Biological: Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1; Biological: Placebo
Group 7ExperimentalSubcutaneous injection in abdomen combined ratio 2 with loading dose 30:3 ratio of Ab:Placebo
Receives: Biological: Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2; Biological: Placebo
Group 8ExperimentalSubcutaneous injection in abdomen combined ratio 3 with loading dose 30:3 ratio of Ab:Placebo
Receives: Biological: Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 3; Biological: Placebo
Group 9ExperimentalSubcutaneous injection in abdomen combined ratio 2 without loading dose 30:3 ratio of Ab:Placebo
Receives: Biological: Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2; Biological: Placebo
Group 10ExperimentalSubcutaneous injection in arm combined ratio 2 without loading dose 30:3 ratio of Ab:Placebo
Receives: Biological: Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2; Biological: Placebo

What is being measured

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

  1. 1. Proportion of participants with solicited and treatment-related unsolicited adverse events and their duration.

    Measured: 92 Weeks

  2. Proportion of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and their duration.

    Measured: 92 Weeks

  3. Serum concentration of each antibody in each group at multiple timepoints along with participant characteristics (e.g. sex, weight, and BMI)

    Measured: 92 Weeks

  4. The ratio of 3BNC117-LS-J to 10-1074-LS-J that, when injected SC, will maintain similar levels of each bNAb at steady state.

    Measured: 92 Weeks

Secondary outcomes (2)

  1. Serum concentration of anti-3BNC117-LS-J antibodies in each group at multiple timepoints.

    Measured: 92 Weeks

  2. Serum concentration of anti-10-1074-LS-J antibodies in each group at multiple timepoints.

    Measured: 92 Weeks

Timeline

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

  1. First posted22 Nov 2019
  2. Study start18 Feb 2020
  3. Primary completion1 Sep 2023
  4. Study completion1 Sep 2023

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a randomized, double-blind, placebo-controlled Phase 1/2 study intended to evaluate the safety and pharmacokinetics of 10-1074-LS-J and 3BNC117-LS-J, alone or in combination, in healthy HIV-uninfected individuals.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04173819
Sponsor's protocol ID
IAVI C100
Status last verified
Nov 2026
First submitted
13 Nov 2019
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weiner JA, Banks LA, Natarajan H, Lin S, Sami S, Kovacikova G, Carpenter MC, Ackerman ME. Drawing a line in the sand: impact of analytical choices on anti-drug antibody cut-points and testing outcomes. Bioanalysis. 2026 Jun-Jun;18(8-9):711-722. doi: 10.1080/17576180.2026.2698615. Epub 2026 Jul 14.

    PubMed 42444466

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 3BNC117-LS-J, 10-1074-LS-J and Combination 3BNC117-LS-J and 10-1074-LS-J in people with HIV-1-infection, run by International AIDS Vaccine Initiative at 9 sites in 5 countries.

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 9 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Kenya, Uganda, Rwanda, South Africa. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

1. Proportion of participants with solicited and treatment-related unsolicited adverse events and their duration. (time frame: 92 Weeks). The study lists 4 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 NCT04173819, 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 4 Nov 2026.

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