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VRC07-523LS
Other Names
VRC-HIVMAB075-00-AB, TMB-380, VRC07-523 (parent bNAb)
Drug Class
Broadly Neutralizing Antibodies
Organization:
VRC07-523LS was developed by the NIAID Vaccine Research Center (VRC).
Phase of Development

VRC07-523LS is in Phase 2 development as a broadly neutralizing antibody for HIV treatment. (VRC07-523LS is also being studied for HIV prevention.)

(Compound details obtained from Treatment Action Group website,1 Protocol HVTN 127/HPTN 087,2 Treatment Action Group Pipeline Report 2025,3 and ClinicalTrials.gov4)

What is VRC07-523LS? What is VRC07-523LS?

What is VRC07-523LS?

VRC07-523LS is an investigational drug that is being studied as a possible strategy to treat people with HIV. VRC07-523LS belongs to a group of 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.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.5,7,8

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 (ART). 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 giving bNAbs, such as VRC07-523LS, to people who do not have HIV can help protect them from getting the virus.3,4 This record focuses on the study of VRC07-523LS as a treatment for HIV.

Select clinical trials of VRC07-523LS Select clinical trials of VRC07-523LS

Select clinical trials of VRC07-523LS

Study Names: IAVI T003; NCT03721510

Phase: 1/2a
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to see how the body handles the bNAbs PGT121, VRC07-523LS, and PGDM1400 and whether these bNAbs are safe and tolerable in adults with and without HIV. Investigators also looked at how well these bNAbs worked in controlling viral load levels after participants temporarily stopped ART (analytical treatment interruption).10
Selected Study Results: Results published in Nat Med (2024) and presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) showed that tbNAb therapy with PGT121, VRC07-523LS, and PGDM1400 was generally safe and well tolerated. Most participants who received bNAb therapy while undergoing an analytical treatment interruption of ART maintained control of viral load levels for at least 28 weeks.11,12

Study Name: NCT04357821

Phase: 1/2
Status: This study is ongoing, but not recruiting participants.
Location: United States
Purpose: The purpose of this study is to see whether a combination regimen can control viral load levels in participants undergoing an analytical treatment interruption of ART. The combination regimen includes (1) therapeutic HIV vaccines, (2) the bNAbs VRC07-523LS and 10-1074, and (3) the latency-reversing agent lefitolimod.13,14
Selected Study Results: Results were presented at CROI 2023 and published in Nature (2026) and showed that most of the participants who received combination therapy had a least partial control of viral load levels after stopping ART.14,15

Study Name: NCT04983030

Phase: 1/2a
Status: This study is has been completed.
Location: United States
Purpose: The purpose of this study was to see whether the combination of therapeutic HIV vaccines and bNAbs (PGT121, PGDM1400, and VRC07-523LS) in adults with viral suppression on ART is safe and could stimulate an immune response in the body. Researchers also looked at whether this combination strategy could control participants’ viral load levels during an analytical treatment interruption of ART.16

Study Name: NCT05275998

Phase: 1b/2a
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to see how the body handles the bNAbs TMB-365 and TMB-380 (also known as VRC07-523LS) and if these bNAbs are safe in people with viral suppression on ART. Researchers also looked at whether the bNAbs could maintain control of participants’ viral load levels after they temporarily stopped ART.17
Selected Study Results: Results were presented at CROI 2025 and showed that TMB-365 and TMB-380 was effective in controlling viral load levels in most participants. The combination of TMB-365 and TMB-380 was generally safe, with no serious or severe side effects reported.18
Additional Published Material:

Study Name: NCT07215468

Phase: 2b
Status: This study is ongoing, but not recruiting participants.
Location: United States
Purpose: The purpose of this study is to find out whether the bNAbs TMB-365 and TMB-380 (also known as VRC07-523LS) are safe and work as well as ART in maintaining control of viral load levels in people with viral suppression.19

Study Names: ACTG A5357; NCT03739996

Phase: 2
Status: This study has been completed.
Locations: United States and Puerto Rico
Purpose: The purpose of this study was to evaluate long-acting cabotegravir (CAB LA) plus VRC07-523LS in adults with viral suppression. Researchers looked at 1) how the body handles CAB LA and VRC07-523LS, 2) whether CAB LA and VRC07-523LS are safe and tolerable, and 3) how well CAB LA and VRC07-523LS work to maintain control of viral load levels.20
Selected Study Results: Results were published in Clin Infect Dis (2026) and presented at CROI 2024 and showed that CAB LA plus VRC07-523LS was safe and worked to maintain control of viral load levels in most of the participants. Eleven participants had severe side effects (mainly temporary infusion reactions), most of which were possibly related to VRC07-523LS. One participant stopped treatment because of a mild infusion reaction.21,22

Study Names: GS-US-382-5445; NCT05281510

Phase: 2a
Status: This study has been completed.
Location: South Africa
Purpose: The purpose of this trial was to evaluate the safety and tolerability of the bNAbs VRC07-523LS and CAP256V2LS in combination with the immune modulator vesatolimod in early ART-treated women with clade C HIV.23
Selected Study Results: Results presented at CROI 2025 and the European AIDS Clinical Society conference (EACS 2025) showed that vesatolimod and the bNAbs VRC07-523LS and CAP256V2LS were safe. There were no treatment-related serious side effects. Most of the participants had mild to moderate infusion reactions that went away within 2 days. One participant discontinued vesatolimod because of a side effect. Participants had varying patterns of viral control during an analytical treatment interruption of ART.24,25
Additional Published Material:

Study Names: A5388; NCT05719441

Phase: 2
Status: This study is currently recruiting participants.
Locations: United States, Brazil, Peru
Purpose: The purpose of this study is to determine whether it is safe to give the bNAbs VRC07-523LS and PGT121.414.LS to adults who are starting ART during the early stage of HIV infection (acute HIV infection). Investigators will also see whether this combination strategy can control viral load levels during an analytical treatment interruption of ART.26

Study Names: IMPAACT 2042; Tatelo Plus Study; NCT06508749

Phase: 1/2
Status: This study is currently recruiting participants.
Location: Botswana
Purpose: The purpose of this study is to evaluate the use of three bNAbs (PGDM1400LS, PGT121.414.LS, and VRC07-523LS) in children with HIV who had started ART early in life. Researchers will look at what impacts the three bNAbs or an analytical treatment interruption ART have on the HIV reservoir, immune function, and the maintenance of viral suppression.27
Selected Study Results: Results from Step 1 of the study were presented at CROI 2026 and showed that infusions of PGDM1400LS, PGT121.414.LS, and VRC07-523LS were safe in children. There were no infusion reactions or serious side effects. Based on data from Step 1, the doses of two of the bNAbs were increased for the next study steps.28

Early results to Step 2 of the study were also presented at CROI 2026. Children received either three or two bNAbs. All of the first 10 participants maintained control of viral load levels for 24 weeks while receiving bNAbs only (without ART). No severe side effects occurred.29

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

Additional early-phase studies evaluating VRC07-523LS for HIV treatment have been completed or are being conducted, including the following trials:

  • VRC 607/ACTG A5378 (NCT02840474) was a Phase 1 trial that looked at whether the bNAbs VRC01LS and VRC07-523LS were safe in adults with HIV who had never received HIV medicines before. Researchers also looked at how well the bNAbs worked to reduce viral load levels. This study has been completed, and results are available from IAS 2019 and JCl Insight (2025).30
  • IAVI T002 (NCT03205917) was a Phase 1 study that evaluated how the body handles the bNAbs PGDM1400, PGT121, and VRC07-523LS and whether these bNAbs are safe and tolerable in adults without HIV and adults with HIV who were not on ART. Investigators also studied how well PGDM1400, PGT121, and VRC07-523LS worked to control viral load levels. This study has been completed, and results are available from CROI 2022 and Nat Med (2022).31
  • ACTG A5386 (NCT04340596) is a Phase 1 trial looking at whether N-803 (an investigational therapy based on the cytokine IL-15), VRC07-523LS, and 10-1074 are safe and effective in controlling viral load levels during an analytical treatment interruption of ART. This study is ongoing, but not recruiting participants. Results are available from CROI 2026 and the International AIDS Conference (AIDS 2026).32
  • RV 630/DELIVER-01 (NCT06484335) is a Phase 1 trial looking at whether the combination of VRC07-523LS, PGDM1400LS, and therapeutic HIV vaccines is safe in adults with HIV who started ART during acute HIV infection. Researchers are also seeing how well this combination works in controlling viral load levels during an analytical treatment interruption of ART. This study is currently recruiting participants. Results to this ongoing study are available from CROI 2026.33
  • NeutART (PACTR202309578224660) is a Phase 1 study looking at whether the bNAbs CAP256V2LS and VRC07-523LS can control viral load in participants undergoing an analytical treatment interruption of ART. See the Pan African Clinical Trials Registry record for this study’s status. Early results are available from AIDS 2026.34
  • A5389 (NCT06987318) is a Phase 1 study evaluating the effectiveness of VRC07-523LS and PGT121.414.LS in controlling viral load levels during an analytical treatment interruption of ART in adults with HIV who had started ART during acute HIV infection. See the ClinicalTrials.gov record for this study’s status.35
  • IMPAACT P1115 (NCT02140255) is a Phase 1/2 trial seeing whether giving intensive ART regimens, with or without bNAbs (VRC01 or VRC07-523LS), to infants early in life can bring about HIV remission. This study is currently recruiting participants. Results thus far are available from CROI 2024, Lancet HIV (2024), Lancet HIV (2025), and CROI 2026 (Posters 839 and 840).36
  • ENABLE 2 (NCT07655141) is a Phase 1/2 study looking at the bNAbs ePGT121v1-LS and VRC07-523LS added to ART in infants with HIV. Researchers will see 1) how the body handles ePGT121v1-LS and VRC07-523LS, 2) whether ePGT121v1-LS and VRC07-523LS are safe, and 3) how well ePGT121v1-LS and VRC07-523LS added to ART work to control viral load levels. See the ClinicalTrials.gov record for this study’s status.37

What side effects might VRC07-523LS cause? What side effects might VRC07-523LS cause?

What side effects might VRC07-523LS cause?

One goal of HIV research is to identify safe new drugs that have fewer side effects. The following side effects were observed in some of the studies of VRC07-523LS listed above.

IAVI T003 (NCT03721510)

In this Phase 1/2a trial, PGT121, VRC07-523LS, and PGDM1400 infusions were reported to be generally safe and well tolerated. Four serious and/or severe side effects occurred during the study but all were considered unrelated to the study bNAbs.10,11

NCT04357821

In this Phase 1/2 trial, 10 participants received a combination regimen consisting of therapeutic HIV vaccines, the bNAbs VRC07-523LS and 10-1074, and the latency-reversing agent lefitolimod. Two participants had higher than normal levels of liver enzymes in their blood. In both participants, liver enzyme levels returned to normal, and there were no long-term problems. Even though the most likely cause of the abnormal liver enzyme levels was unrelated to the study drugs, researchers could not completely rule out the study drugs as a cause.13,14

NCT05275998

In the first part of this Phase 1b/2a trial, safety data from 30 participants who received single infusions of TMB-365 and TMB-380 (VRC07-523LS) showed that both bNAbs were safe at all three dose levels studied. No serious or severe side effects were reported. Twenty-three participants reported mild or moderate side effects, and five side effects were considered probably or definitely related to bNAb infusions. Two participants in the mid-dose group had a hypersensitivity reaction (fatigue and chills) to bNAb infusions. Other side effects related to the bNAbs included coldness in hands and/or feet, fatigue, and sneezing.38

In the second part of this study, 21 participants received at least one infusion of TMB-365 and TMB-380. Two participants discontinued treatment because of moderately severe drug-related rash. There were no serious or severe side effects, and no acute infusion reactions were reported. (Acute infusion reactions are infusion-related side effects occurring during or shortly after an infusion.) Side effects that were possibly or probably related to bNAb infusions occurred in eight participants and included rash, fatigue, headache, flushing, fever, chills, and aches.18

ACTG A5357 (NCT03739996)

In Step 2 of this Phase 2 trial, 71 participants received long acting cabotegravir (CAB LA) plus VRC07-523LS for up to 48 weeks. One participant discontinued treatment because of a temporary and mild infusion reaction they experienced after receiving VRC07-523LS. Eight participants had severe side effects that were possibly related to VRC07-523LS, which included chills, feeling unwell, fatigue, generalized aching, narrowing of the blood vessels, low blood pressure, muscle pain, and headache. One participant had severe elevated liver enzyme levels, which was possibly related to both CAB LA and VRC07-523LS.22,39

GS-US-382-5445 (NCT05281510)

In this Phase 2a trial, 20 participants received vesatolimod and infusions of the bNAbs VRC07-523LS and CAP256VLS. Side effects related to treatment were mostly mild and occurred in 18 participants. The most common side effects related to treatment were infusion reactions, headache, abnormally fast heart rate, fever, and chest discomfort. Two participants had severe treatment-related side effects—fever and chills. Most of the treatment-related infusion reactions associated with the bNAbs were mild and all of these reactions went away within 2 days. No treatment-related serious side effects were reported.24,25

IMPAACT 2042 (Tatelo Plus Study; NCT06508749)

In In this ongoing Phase 1/2 trial, infusions of PGDM1400LS, PGT121.414.LS, and VRC07-523LS in children were well tolerated. No severe side effects occurred and no infusion-related reactions were reported during the first study step.27–29

Because VRC07-523LS is still being studied, information on possible side effects of the drug is not complete. As testing of VRC07-523LS continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying VRC07-523LS? Where can I get more information about clinical trials studying VRC07-523LS?

Where can I get more information about clinical trials studying VRC07-523LS?

More information about VRC07-523LS-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 a clinical trial 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 29, 2026
  2. HIV Vaccine Trials Network and HIV Prevention Trials Network. Protocol HVTN 127/HPTN 087: a multicenter, randomized phase 1 clinical trial to evaluate the safety and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses, routes, and dosing schedules to healthy, HIV-uninfected adults [Version 1.0]; November 28, 2017. Accessed July 29, 2026
  3. Jefferys R. The HIV vaccines and passive immunization pipeline report 2025. Treatment Action Group Pipeline Report 2025. Accessed July 29, 2026
  4. National Institute of Allergy and Infectious Diseases (NIAID). A randomized, double blind, controlled, Phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 31, 2025. NLM Identifier: NCT06812494. Accessed July 29, 2026
  5. HIV Vaccine Trials Network (HVTN). Using antibodies for HIV prevention. Accessed July 29, 2026
  6. Snow B. The rise of broadly neutralizing antibodies. AIDS Vaccine Advocacy Coalition (AVAC). Published May 17, 2018. Accessed July 29, 2026
  7. National Institute of Allergy and Infectious Diseases (NIAID). Sustained ART-free HIV remission. Accessed July 29, 2026
  8. National Institute of Allergy and Infectious Diseases (NIAID). Future directions for HIV treatment research. Accessed July 29, 2026
  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. Accessed July 29, 2026
  10. International AIDS Vaccine Initiative. A Phase 1/2a open label study of the safety, tolerability, pharmacokinetics and antiviral activity of PGT121, VRC07-523LS and PGDM1400 monoclonal antibodies in HIV-uninfected and HIV-infected adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 16, 2018. NLM Identifier: NCT03721510. Accessed July 29, 2026
  11. Juelg BD, Walker-Sperling VE, Wagh K, et al. Therapeutic efficacy of a triple combination of HIV-1 broadly neutralizing antibodies. Webcast presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2024; Denver, CO. Accessed July 29, 2026
  12. Julg B, Walker-Sperling VEK, Wagh K, et al. Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial. Nat Med. 2024;30(12):3534-3543. doi:10.1038/s41591-024-03247-5. Accessed July 29, 2026
  13. University of California, San Francisco. Combinatorial therapy with a therapeutic conserved element DNA vaccine, MVA vaccine boost, TLR9 agonist and broadly neutralizing antibodies: a proof-of-concept study aimed at inducing an HIV remission. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 18, 2020. NLM Identifier: NCT04357821. Accessed July 29, 2026
  14. Peluso M, Deitchman A, Magombedze G, et al. Rebound dynamics following immunotherapy with an HIV vaccine, TLR-9 agonist, and broadly neutralizing antibodies. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 19-22, 2023; Seattle, WA. Poster 435. Accessed July 29, 2026
  15. Peluso MJ, Sandel DA, Deitchman AN, et al. Correlates of HIV-1 control after combination immunotherapy. Nature. 2026;650(8100):187-195. doi:10.1038/s41586-025-09929-5. Accessed July 29, 2026
  16. Boris Juelg, MD PhD. A safety, immunogenicity and efficacy Phase 1/2a study of a heterologous Ad26.Mos4.HIV, MVA-BN-HIV vaccine regimen plus broadly neutralizing antibodies PGT121, PGDM1400, and VRC07-523LS in HIV-1-infected adults on suppressive ART. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 5, 2021. NLM Identifier: NCT04983030. Accessed July 29, 2026
  17. TaiMed Biologics Inc. A Phase 1b/2a dose escalation study of the safety, pharmacokinetics, and efficacy of the combination of TMB-365 and TMB-380 in HIV-1 infected individuals suppressed with combination antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 2, 2022. NLM Identifier: NCT05275998. Accessed July 29, 2026
  18. Lalezari JP, DeJesus E, Sension MG, et al. A 24-week Phase II maintenance study of TMB-365/TMB-380 Q8W in people with suppressed HIV-1 infection. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 9-12, 2025; San Francisco, CA. Poster 701. Accessed July 29, 2026
  19. TaiMed Biologics Inc. A Phase 2b study of the safety, pharmacokinetics, and efficacy of the combination of TMB-365 and TMB-380 as maintenance therapy in HIV-1 infected individuals suppressed with combination antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 9, 2025. NLM Identifier: NCT07215468. Accessed July 29, 2026
  20. National Institute of Allergy and Infectious Diseases (NIAID). A study of long-acting cabotegravir plus VRC01LS to maintain viral suppression in adults living with HIV-1. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 9, 2018. NLM Identifier: NCT03739996. Accessed July 29, 2026
  21. Taiwo BO, Zheng Y, Rodriguez K, et al. Phase 2 Trial of Long-Acting Cabotegravir and VRC07-523LS for Viral Suppression in Adults With HIV-1: ACTG A5357. Clin Infect Dis. 2026;82(1):100-108. doi:10.1093/cid/ciaf375. Accessed July 29, 2026
  22. Taiwo B, Zheng YE, Rodriguez K, et al. Safety and efficacy of VRC07-523LS plus long-acting cabotegravir in the Phase II ACTG A5357 trial. Abstract presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2024; Denver, CO. Abstract 119. Accessed July 29, 2026
  23. Gilead Sciences. A Phase 2a study to evaluate the safety and tolerability of a regimen of dual anti-HIV envelope antibodies, VRC07-523LS and CAP256V2LS, in a sequential regimen with a TLR7 agonist, vesatolimod, in early antiretroviral-treated HIV-1 clade C-infected women. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 7, 2022. NLM Identifier: NCT05281510. Accessed July 29, 2026
  24. Dong K, Asari V, Govender V, et al. Evaluation of 2 bNAbs plus vesatolimod in early-treated South African women with HIV-1 during ATI. Abstract presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 9-12, 2025; San Francisco, CA. Abstract 105. Accessed July 29, 2026
  25. Lim D, Fu Olivia, Liu Xiaopeng, et al. Safety and analytical treatment interruption outcomes in a clinical trial of 2 broadly neutralizing antibodies plus vesatolimod in early-treated South African women with clade C HIV-1. European AIDS Conference; October 15-18, 2025; Paris, France. Conference Reports for National AIDS Treatment Advocacy Project (NATAP); 2025. Accessed July 29, 2026
  26. National Institute of Allergy and Infectious Diseases (NIAID). A double-blind, randomized, placebo-controlled clinical trial of combination HIV-specific broadly neutralizing monoclonal antibodies combined with ART initiation during acute HIV infection to induce HIV remission. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 30, 2023. NLM Identifier: NCT05719441. Accessed July 29, 2026
  27. National Institute of Allergy and Infectious Diseases (NIAID). Phase I/II trial to evaluate the impact of three broadly neutralizing antibodies or analytic treatment interruption on viral reservoir, immune function, and maintenance of HIV suppression in early treated children in Botswana. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 26, 2024. NLM Identifier: NCT06508749. Accessed July 29, 2026
  28. Capparelli EV, Ajibola G, Nelson BS, et al. Safety and Pharmacokinetics of VRC07-523LS, PGDM1400LS, and PGT121.414.LS in combination among children in Botswana. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2026; Denver, CO. Poster 843. Accessed July 29, 2026
  29. Ajibola G, Sakoi-Mosetlhi M, Batlang O, et al. Viral control among children in Botswana receiving combination broadly neutralizing antibodies. Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2026; Denver, CO. Conference Reports for National AIDS Treatment Advocacy Project (NATAP); 2026. Accessed July 29, 2026
  30. National Institute of Allergy and Infectious Diseases (NIAID). VRC 607-ACTG A5378: a phase 1, single dose study of the safety and virologic effect of an HIV-1 specific broadly neutralizing human monoclonal antibody, VRC-HIVMAB080-00-AB (VRC01LS) or VRC-HIVMAB075-00-AB (VRC07-523LS), administered intravenously to HIV-infected adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered July 19, 2016. NLM Identifier: NCT02840474. Accessed July 29, 2026
  31. International AIDS Vaccine Initiative. A Phase 1 randomized placebo-controlled clinical trial of the safety, pharmacokinetics and antiviral activity of PGDM1400 and PGT121 and VRC07-523LS monoclonal antibodies in HIV-uninfected and HIV-infected adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 12, 2017. NLM Identifier: NCT03205917. Accessed July 29, 2026
  32. National Institute of Allergy and Infectious Diseases (NIAID). A Phase I clinical trial of the safety, tolerability, and efficacy of IL-15 superagonist (N-803) with and without combination broadly neutralizing antibodies to induce HIV-1 control during analytic treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 23, 2020. NLM Identifier: NCT04340596. Accessed July 29, 2026
  33. Henry M. Jackson Foundation for the Advancement of Military Medicine. Approach to control HIV with immune enhancement and vaccination (ACHIEV): safety and efficacy of broadly neutralizing antibodies combined with therapeutic vaccination for the induction of HIV remission. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 31, 2024. NLM Identifier: NCT06484335. Accessed July 29, 2026
  34. Centre for the AIDS Programme of Research in South Africa. Phase 1 study to evaluate if broadly neutralizing monoclonal antibodies CAP256V2LS and VRC07-523LS, combined with antiretroviral therapy (ART), will result in sustained virological control following analytical treatment interruption. Pan African Clinical Trials Registry. Trial no.: PACTR202309578224660. Accessed July 29, 2026
  35. National Institute of Allergy and Infectious Diseases (NIAID). A Phase I study to evaluate the safety and antiviral activity of two human monoclonal antibodies (VRC07-523LS and PGT121.414.LS) during analytic treatment interruption in participants living with HIV who initiated ART during acute/early HIV-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 25, 2025. NLM Identifier: NCT06987318. Accessed July 29, 2026
  36. National Institute of Allergy and Infectious Diseases (NIAID). Very early intensive treatment of infants living with HIV to achieve HIV remission: a Phase I/II proof of concept study. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 13, 2014. NLM Identifier: NCT02140255. Accessed July 29, 2026
  37. Hospital Universitario 12 de Octubre. A Phase 1/2 trial evaluating the safety, pharmacokinetics, and antiviral activity of subcutaneous ePGT121v1-LS in combination with VRC07-523LS, added to standard antiretroviral therapy in infants living with HIV. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 9, 2026. NLM Identifier: NCT07655141. Accessed July 29, 2026
  38. Lalezari JP, Ramgopal M, Richmond G, et al. A dose escalation study of safety & PK of TMB-365 & TMB-380 in people with suppressed HIV. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2024, 2024; Denver, CO. Poster 640. Accessed July 29, 2026
  39. Taiwo B, Zheng YE, Rodriguez K, et al. Safety and efficacy of VRC07-523LS plus long-acting cabotegravir in the Phase II ACTG A5357 trial. Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2024; Denver, CO. Conference Reports for National AIDS Treatment Advocacy Project (NATAP); 2024. Accessed July 29, 2026

Last Reviewed: July 29, 2026