Drug information

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Other Names:
3BNC117-LS
Drug Class:
Broadly Neutralizing Antibodies
Registry Number:
1412902-17-0 (CAS)
Organization:
Rockefeller University
Phase of Development:

3BNC117 is in Phase 2 development as a broadly neutralizing antibody for HIV treatment. (3BNC117 is also being developed for HIV prevention.)

(Compound details obtained from ChemIDplus Advanced,1 Nature article,2 Treatment Action Group website,and ClinicalTrials.gov4)

 
What is 3BNC117?What is 3BNC117?

What is 3BNC117?

 

3BNC117 is an investigational drug that is being studied as a possible strategy to treat people living with HIV. 3BNC117 belongs to a group of drugs called broadly neutralizing antibodies (bNAbs).3

To learn how investigational vaccines and drugs are tested during clinical trials, read the ClinicalInfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

How do broadly neutralizing antibodies work?How do broadly neutralizing antibodies work?

How do broadly neutralizing antibodies work?

Antibodies are proteins that the immune system makes to fight infection. A person with HIV produces specific antibodies against HIV. However, most of these antibodies do not stop HIV from multiplying in the body.5,6

Some people with HIV naturally produce rare types of HIV antibodies called broadly neutralizing antibodies (bNAbs). bNAbs are powerful antibodies that can work against different HIV strains. bNAbs can block HIV from entering healthy cells and activate other immune cells to help destroy infected cells.6–8

Researchers are investigating whether giving bNAbs to people with HIV can help them maintain undetectable levels of HIV without the need for daily antiretroviral therapy. Additionally, some bNAbs are being studied because they may be able to reduce the size of the latent HIV reservoir.7,9

Researchers are also trying to find out if 3BNC117 can prevent HIV infection in people who do not have the virus.10 This record focuses on the study of 3BNC117 as a treatment for HIV.

Which clinical trials are studying 3BNC117?Which clinical trials are studying 3BNC117?

Which clinical trials are studying 3BNC117?

 

Study Name: NCT02588586
Phase: 2
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of 3BNC117 and its ability to delay or prevent an increase in viral load levels during a structured treatment interruption of ART.11

Study Name: NCT02446847
Phase: 2a
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety and drug properties of 3BNC117. The study also examined how well 3BNC117 could delay or prevent an increase in viral load levels during a structured treatment interruption of ART.2,12

Study Names: ROADMAP; NCT02850016
Phase: 1b/2a
Status: This study is ongoing, but not recruiting participants.
Location: Not available.
Purpose: The purpose of this study is to compare the efficacy of romidepsin plus 3BNC117 to the efficacy of romidepsin alone on delaying or preventing an increase in viral load during a structured treatment interruption of ART.13,14

Study Names: eCLEAR; NCT03041012
Phase: 2
Status: This study is currently recruiting participants. 
Locations: Denmark and United Kingdom
Purpose: The purpose of this study is to evaluate whether the early administration of romidepsin and/or 3BNC117 in people who have never taken HIV medicines before and who are now going to start them can limit the size of the latent HIV reservoir.15

Study Names: TITAN; NCT03837756
Phase: 2a
Status: This study is currently recruiting participants.
Locations: Australia, Denmark, United States
Purpose: The purpose of this study is to evaluate the safety and effectiveness of lefitolimod and the bNAbs 3BNC117 and 10-1074 in delaying the time to re-initiate ART during a structured treatment interruption of ART.16

Study Name: NCT03719664
Phase: 2
Status: This study is currently recruiting participants.
Location: United States
Purpose: The purpose of this study is to determine the most effective dose of 3BNC117 and albuvirtide and evaluate the safety and effectiveness of this combination as long-acting maintenance treatment.17

Study Names: RIO; NCT04319367
Phase: 2
Status: See the ClinicalTrials.gov record for this study's status.
Location: United Kingdom
Purpose: The purpose of this study is to determine whether the combination of the two long-acting bNAbs 3BNC117-LS and 10-1074-LS can prevent viral rebound after a structured treatment interruption of ART.18

For more details on the studies listed above, see the Health Professional version of this drug summary.

Additional studies evaluating 3BNC117 for HIV treatment either have been conducted or will be conducted, including the following early-phase trials of 3BNC117 and 10-1074:

  • NCT03526848, a Phase 1 study that is assessing whether 3BNC117 and 10-1074 can prevent viral rebound in adults with HIV during a structured treatment interruption of ART. This study is ongoing, but not recruiting participants.19
  • NCT03571204: A Phase 1 study evaluating whether 3BNC117 and 10-1074 can control viral load levels in individuals with HIV who are currently not taking HIV medicines and in individuals with HIV who stop taking HIV medicines during a structured treatment interruption. This study is currently recruiting participants.20
  • NCT03554408: A Phase 1 study investigating the safety and pharmacokinetics of 10-1074-LS when given alone and when given in combination with 3BNC117-LS in adults with and without HIV. This study is ongoing, but not recruiting participants.21
  • BEAT-2 (NCT03588715): A Phase 1 study that will evaluate whether peginterferon alfa-2b (HIV) and 3BNC117 and 10-1074 can control viral rebound and reduce the latent HIV reservoir in adults with HIV during a structured treatment interruption of ART. See the ClinicalTrials.gov record for this study's status.22
  • NCT04250636: A Phase 1 study that will evaluate the safety, pharmacokinetics, and antiviral activity of single infusions of both 3BNC117-LS and 10-1074-LS in adults with HIV who are off ART. See the ClinicalTrials.gov record for this study's status.23
What side effects might 3BNC117 cause?What side effects might 3BNC117 cause?

What side effects might 3BNC117 cause?

 

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of 3BNC117 listed above. 

NCT02446847:
In this study, most side effects were temporary and mild. Some participants experienced modest drops in their CD4 counts during the study, but most had their counts return to normal levels by Week 12.2

ROADMAP (NCT02850016):
In the ROADMAP trial, most of the side effects reported during the study were mild. About 27% of the side effects that occurred were at least possibly related to romidepsin or 3BNC117. The most common side effects were nausea, headache, fatigue, general discomfort, chills, and vomiting.13,14,24

Because 3BNC117 is still being studied, information on possible side effects of the drug is not complete. As testing of 3BNC117 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying 3BNC117?Where can I get more information about clinical trials studying 3BNC117?

Where can I get more information about clinical trials studying 3BNC117?

 

More information about 3BNC117-related research studies is available from ClinicalTrials.gov.

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.

ReferencesReferences

References

 

  1. United States National Library of Medicine. ChemIDplus Advanced: 3BNC117. https://chem.nlm.nih.gov/chemidplus/rn/1412902-17-0. Accessed April 28, 2020
  2. Scheid JF, Horwitz JA, Bar-On Y, et al. HIV-1 antibody 3BNC117 suppresses viral rebound in humans during treatment interruption. Nature. 2016;535(7613):556-560.
  3. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed April 28, 2020
  4. Rockefeller University. A Phase 1 study of the safety and pharmacokinetics of the combination of 3BNC117 and 10-1074 in HIV-uninfected adults: In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 28, 2016. NLM Identifier: NCT02824536. https://clinicaltrials.gov/ct2/show/NCT02824536. Accessed April 28, 2020
  5. Snow B. The rise of broadly neutralizing antibodies. AIDS Vaccine Advocacy Coalition (AVAC). Published May 17, 2018. https://www.avac.org/blog/rise-broadly-neutralizing-antibodies. Accessed April 28, 2020
  6. HIV Vaccine Trials Network (HVTN). Using antibodies for HIV prevention. https://www.hvtn.org/en/science/hiv-vaccine-basics/why-hiv-vaccine1.html. Accessed April 28, 2020
  7. National Institute of Allergy and Infectious Diseases (NIAID). Sustained ART-free HIV remission. https://www.niaid.nih.gov/diseases-conditions/sustained-art-free-hiv-remission. Accessed April 28, 2020
  8. National Institute of Allergy and Infectious Diseases (NIAID). Future directions for HIV treatment research. https://www.niaid.nih.gov/diseases-conditions/future-hiv-treatment. Accessed April 28, 2020
  9. Grobben M, Stuart RA, van Gils MJ. The potential of engineered antibodies for HIV-1 therapy and cure. Curr Opin Virol. 2019;38:70-80. doi:10.1016/j.coviro.2019.07.007
  10. Jefferys R. HIV vaccines, passive immunization, and antibody gene transfer. Treatment Action Group Pipeline Report 2019. https://www.treatmentactiongroup.org/wp-content/uploads/2019/09/pipeline_hiv_vax_immune_gene_transfer_2019.pdf. Accessed April 28, 2020
  11. Rockefeller University. An open label, Phase 2 study of the safety and antiretroviral activity of 3BNC117 in HIV-infected individuals on combination antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 26, 2015. NLM Identifier: NCT02588586. https://clinicaltrials.gov/ct2/show/NCT02588586. Accessed April 28, 2020
  12. Rockefeller University. A Phase 2, open label study of the safety, antiretroviral activity and pharmacokinetics of 3BNC117 during a short analytical treatment interruption in HIV-infected subjects. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 17, 2015. NLM Identifier: NCT02446847. https://clinicaltrials.gov/ct2/show/NCT02446847. Accessed April 28, 2020
  13. Rockefeller University. A Phase 2a, randomized study of romidepsin with or without 3BNC117 to evaluate the effects on the HIV-1 reservoir (ROADMAP). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 26, 2016. NLM Identifier: NCT02850016. https://clinicaltrials.gov/ct2/show/NCT02850016. Accessed April 28, 2020
  14. Gruell H, Cohen YZ, Gunst JD, et al. A randomized trial of the impact of 3BNC117 and romidepsin on the HIV-1 reservoir. Abstract presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 8-11, 2020; Boston, MA. Abstract 38. https://www.croiconference.org/abstract/a-randomized-trial-of-the-impact-of-3bnc117-and-romidepsin-on-the-hiv-1-reservoir/. Accessed April 28, 2020
  15. Aarhus University Hospital. Early administration of latency reversing therapy and broadly neutralizing antibodies to limit the establishment of the HIV-1 reservoir during initiation of antiretroviral treatment - a randomized controlled trial. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 20, 2017. NLM Identifier: NCT03041012. https://clinicaltrials.gov/ct2/show/NCT03041012. Accessed April 28, 2020
  16. University of Aarhus. Combining a TLR9 agonist with broadly neutralizing antibodies for reservoir reduction and immunological control of HIV infection: an investigator-initiated randomized, placebo-controlled, Phase IIa trial. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 7, 2019. NLM Identifier: NCT03837756. https://clinicaltrials.gov/ct2/show/NCT03837756. Accessed April 28, 2020
  17. Frontier Biotechnologies Inc. A Phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 22, 2018. NLM Identifier: NCT03719664. https://clinicaltrials.gov/ct2/show/NCT03719664. Accessed April 28, 2020
  18. Imperial College London. A randomised placebo controlled trial of ART plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) vs ART plus placebo in treated primary HIV infection on viral control off ART. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 2, 2020. NLM Identifier: NCT04319367. https://clinicaltrials.gov/ct2/show/NCT04319367. Accessed April 28, 2020
  19. Rockefeller University. 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. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 3, 2018. NLM Identifier: NCT03526848. https://clinicaltrials.gov/ct2/show/NCT03526848. Accessed April 28, 2020
  20. National Institute of Allergy and Infectious Diseases (NIAID). An exploratory study of combination therapy with 3BNC117 and 10-1074 in HIV-infected individuals. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 22, 2018. NLM Identifier: NCT03571204. https://clinicaltrials.gov/ct2/show/NCT03571204. Accessed April 28, 2020
  21. Rockefeller University. A Phase 1, dose escalation, first-in-human study of the safety and pharmacokinetics of the subcutaneous and intravenous administration of 10-1074-LS alone and in combination with 3BNC117-LS in HIV-infected and HIV-uninfected individuals. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 26, 2016. NLM Identifier: NCT03554408. https://clinicaltrials.gov/ct2/show/NCT03554408. Accessed April 28, 2020
  22. Luis Montaner. Pilot study on innate activation and viral control in HIV-infected adults undergoing an analytical treatment interruption after administration of pegylated interferon alpha 2b with broadly HIV-1 neutralizing antibodies (3BNC117, 10-1074). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 17, 20185. NLM Identifier: NCT03588715. https://clinicaltrials.gov/ct2/show/NCT03588715. Accessed April 28, 2020
  23. Rockefeller University. An open label, single arm study of the safety, pharmacokinetics and antiretroviral activity of the combination of 3BNC117-LS and 10-1074-LS in viremic HIV-infected individuals. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 30, 2020. NLM Identifier: NCT04250636. https://clinicaltrials.gov/ct2/show/NCT04250636. Accessed April 28, 2020
  24. Søgaard OS. A randomized trial of the impact of 3BNC117 and romidepsin on the HIV-1 reservoir. Webcast presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 8-11, 2020; Boston, MA. http://www.croiwebcasts.org/console/player/44589?mediaType = slideVideo&. Accessed April 28, 2020
 

Last Reviewed: April 28, 2020