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GSK3810109A
Other Names
N6LS; VH3810109; VRC-HIVMAB091-00-AB; GSK3810109 and N6 (parent bNAb)
Drug Class
Broadly Neutralizing Antibodies
Organization
National Institute of Allergy and Infectious Diseases (NIAID); GlaxoSmithKline; ViiV Healthcare
Phase of Development

GSK3810109A is in Phase 2a development as a broadly neutralizing antibody for HIV treatment. (GSK3810109A has also been studied for HIV prevention.)

(Compound details obtained from Treatment Action Group website,1 ViiV Healthcare press release,2ClinicalTrials.gov,3,4 and Treatment Action Group Pipeline Report 20225)

 
What is GSK3810109A? What is GSK3810109A?

What is GSK3810109A?

GSK3810109A is an investigational drug that is being studied as a possible strategy to treat people living with HIV. GSK3810109A belongs to a group of HIV drugs called broadly neutralizing antibodies (bNAbs).1

To learn how investigational drugs are tested during clinical trials, read the HIVinfo What is an investigational HIV Drug? and HIV and 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.6,7

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.7–9

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.8,9

Researchers have also studied GSK3810109A for HIV prevention.3–5 This record focuses on the study of GSK3810109A as a treatment for HIV.

Which clinical trials are studying GSK3810109A? Which clinical trials are studying GSK3810109A?

Which clinical trials are studying GSK3810109A?

Study Names: BANNER Study; NCT04871113

Phase: 2a
Status: This study is ongoing, but not recruiting participants.
Locations: United States, Argentina, Brazil, Canada, and Mexico
Purpose: The purpose of this trial is to evaluate the antiviral activity, safety, and tolerability of GSK3810109A administered at two dose levels in treatment-naive adults.
Selected Study Results: Results presented at HIV Glasgow 2022 showed that a single infusion of GSK3810109A monotherapy, at both high- and low-dose levels, led to robust antiviral efficacy in 13 out of 14 treatment-naive participants. No serious side effects were reported, and few drug-related side effects occurred. All injection-site reactions and drug-related side effects were mild.10
Additional Published Material:


For more details on this study, see the Health Professional version of this drug summary.

What side effects might GSK3810109A cause? What side effects might GSK3810109A cause?

What side effects might GSK3810109A cause?

One goal of HIV research is to identify new drugs that have fewer side effects. In the BANNER study (NCT04871113) discussed under the previous question, 14 participants received a single intravenous infusion of GSK3810109A monotherapy. Only one participant in the high-dose group and two participants in the low-dose group experienced drug-related side effects, all of which were mild. Drug-related side effects included abdominal pain, gastrointestinal pain, itching, asthenia, and myalgia. Two participants in the high-dose group had a mild injection-site reaction—skin redness and pain in one participant each. No serious side effects were reported.10

Because GSK3810109A is still being studied, information on possible side effects of the drug is not complete. As testing of GSK3810109A continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying GSK3810109A? Where can I get more information about clinical trials studying GSK3810109A?

Where can I get more information about clinical trials studying GSK3810109A?

More information about GSK3810109A-related research studies is available from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)

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

References References

References

  1. Treatment Action Group website. Research toward a cure trials. Accessed July 12, 2023
  2. ViiV Healthcare: Press release, dated November 21, 2019. ViiV Healthcare announces exclusive licensing agreement with the National Institutes of Health for investigational “bNAb” with potential for long-acting HIV treatment and prevention. Accessed July 12, 2023
  3. National Institute of Allergy and Infectious Diseases (NIAID). A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of a human monoclonal antibody, VRC-HIVMAB091-00-AB (N6LS), administered intravenously or subcutaneously with or without recombinant human hyaluronidase PH20 (rHuPH20) to healthy adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 24, 2018. NLM Identifier: NCT03538626. Accessed July 12, 2023
  4. ViiV Healthcare. A Phase 1, open-label, single-dose study of the safety and pharmacokinetics of a human monoclonal antibody, GSK3810109, administered either subcutaneously or intravenously with recombinant human hyaluronidase PH20 (rHuPH20) to healthy adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 16, 2022. NLM Identifier: NCT05291520. Accessed July 12, 2023
  5. Jefferys R. HIV vaccines & passive immunization. Treatment Action Group Pipeline Report 2022. Accessed July 12, 2023
  6. Snow B. The rise of broadly neutralizing antibodies. AIDS Vaccine Advocacy Coalition (AVAC). Published May 17, 2018. Accessed July 12, 2023
  7. HIV Vaccine Trials Network (HVTN). Using antibodies for HIV prevention. Accessed July 12, 2023
  8. National Institute of Allergy and Infectious Diseases (NIAID). Sustained ART-free HIV remission. Accessed July 12, 2023
  9. National Institute of Allergy and Infectious Diseases (NIAID). Future directions for HIV treatment research. Accessed July 12, 2023
  10. Leone P, Ferro A, Rolle C-P, et al. VH3810109 (N6LS) reduces viremia across a range of doses in ART-naive adults living with HIV: proof of concept achieved in the Phase IIa BANNER (207959, NCT04871113) Study. Slides presented at: HIV Drug Therapy Glasgow; October 23-26, 2022; Virtual and Glasgow, United Kingdom. Accessed July 12, 2023

     

Last Reviewed: July 12, 2023