Drug information

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VRC07-523LS
Other Names
VRC-HIVMAB075-00-AB, TMB-380, VRC07-523 (parent bNAb)
Drug Class
Broadly Neutralizing Antibodies
Organization:
National Institute of Allergy and Infectious Diseases (NIAID)
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 NIAID Therapeutics Database,1 Treatment Action Group website,2 and Treatment Action Group Pipeline Report 2024,3 and ClinicalTrials.gov4)

Pharmacology Pharmacology

Pharmacology

Mechanism of Action

Broadly neutralizing antibody (bNAb). VRC07-523LS is a recombinant human IgG1 monoclonal antibody belonging to the VRC01 antibody class. It is an optimized version of the bNAb VRC07 and contains an LS mutation which prolongs its plasma half-life. VRC07-523LS is a second-generation bNAb that targets the CD4 binding site on HIV envelope gp120 and has broad and potent neutralizing activity against 96% of a large panel of viral strains.5–8

Second-generation HIV bNAbs are naturally occurring antibodies with potent neutralizing activity against a broad array of HIV strains. The utility of bNAbs is being researched for both HIV prevention and treatment/cure. By binding to sites on HIV envelope and through Fc receptor interactions, bNAbs can potentially 1) inhibit cell-free and cell-to-cell viral entry, 2) induce cellular phagocytosis and destruction by macrophages or antibody dependent cellular cytotoxicity (ADCC) by natural killer (NK) cells, and 3) promote the maturation and activity of dendritic cells.8–11 Because it is difficult to induce in vivo generation of bNAbs using conventional vaccination techniques, bNAbs may need to be given by passive transfer, whereby a bNAb is directly administered to an individual.9,12

VRC07-523LS is being studied for HIV prevention and is also being developed as a possible component to HIV treatment or cure.2–4

Half-life (T½)

In a Phase 1 study (NCT03387150) of VRC07-523LS administered via different routes and doses in healthy adults without HIV, the estimated mean half-life of VRC07-523LS was 42 days.13,14

Resistance

The IAVI T003 study (NCT03721510) evaluated monthly infusions of triple bNAb therapy (PGT121, PGDM1400, and VRC07-523LS) in 12 participants with viral suppression. Two participants who had viral rebound early in the study were found to have pre-existing baseline virus that was resistant to PGT121 and PGDM1400. In one of the two participants, the rebound virus selected for new PGT121 and VRCC07-523LS mutations, which were not present at baseline. Five participants experienced late viral rebound with low plasma levels of PGT121 and PGDM1400 but high levels of VRC07-523LS. One of the five participants received only three doses of triple bNAb infusions, and late rebound occurred despite having virus that was susceptible to the three bNAbs. In a second participant, the virus at rebound was found to be susceptible to VRC07-523LS but fully resistant to PGT121 and PGDM1400. In a third participant, rebound occurred with virus that was sensitive to VRC07-523LS but had intermediate resistance to PGT121 and PGDM1400.15,16

Select Clinical Trials Select Clinical Trials

Select Clinical Trials

Study Identifiers: IAVI T003; NCT03721510

Sponsor: International AIDS Vaccine Initiative
Phase: 1/2a
Status: This study has been completed.
Study Purpose: The purpose of this open-label study was to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the bNAbs PGT121, VRC07-523LS, and PGDM1400 in adults with and without HIV.
Study Population:

  • Participants were adults with and without HIV.
  • Participants with HIV had been on ART for at least 24 months, had HIV RNA <50 copies/mL for at least 12 months and at screening, and had CD4 counts ≥400 cells/mm3.15

Selected Study Results: Results published in Nature Medicine (2024) and presented at CROI 2024 showed that triple bNAb therapy with PGT121, VRC07-523LS, and PGDM1400 was generally safe and well tolerated. Most participants (83%) who received bNAb therapy while undergoing an analytical treatment interruption (ATI) of ART maintained viral suppression for at least 28 weeks (duration of the dosing period). Although bNAb concentrations declined to low or undetectable levels during the follow-up period, 42% of the participants had viral suppression for at least 38 to 44 weeks.16,17

Study Identifier: NCT04357821

Sponsor: University of California, San Francisco
Phase: 1/2
Status: This study is ongoing, but not recruiting participants.
Study Purpose: The purpose of this open-label study is to evaluate whether a combination regimen can control viral load levels in participants undergoing an ATI. The combination regimen includes (1) therapeutic HIV vaccines (Gag conserved element [CE]-targeted DNA+IL-12 prime/MVA boost vaccination), (2) bNAbs VRC07-523LS and 10-1074, and (3) the TLR9 agonist lefitolimod.
Study Population:

  • Participants are adults with HIV who have been on a continuous ART regimen for at least 12 months and a stable ART regimen that does not include an NNRTI for at least 4 weeks.
  • Participants have had undetectable HIV RNA in the past 24 months and have CD4 counts ≥500 cells/mm3 at screening.18,19

Selected Study Results: Results presented at CROI 2023 indicated that most participants (seven out of 10) who received combination therapy had a least partial virologic control after ART interruption. The average time to viral rebound following ART interruption was 15 weeks.19

Study Identifier: NCT04983030

Sponsor: Boris Juelg, MD PhD
Phase: 1/2a
Status: This study is ongoing, but not recruiting participants.
Study Purpose: The purpose of this study is to evaluate the safety, immunogenicity, and efficacy of therapeutic HIV vaccines (Ad26.Mos4.HIV prime and MVA-BN-HIV boost) in combination with bNAbs (PGT121, PGDM1400, and VRC07-523LS) in adults on suppressive ART. Researchers will assess whether this combination strategy can control participants’ viral load levels during an ATI of ART.
Study Population:

  • Participants are adults with HIV who have been on a suppressive ART regimen for at least 48 weeks prior to screening.
  • Participants have HIV RNA <50 copies/mL at screening and at least one documented result of HIV RNA <50 copies/mL after the last ART change.
  • Participants have CD4 counts >450 cells/mm3 at screening and at least one documented result >300 cells/mm3 within the past 48 weeks prior to randomization.20

Study Identifier: NCT05275998

Sponsor: TaiMed Biologics Inc.
Phase: 1b/2a
Status: This study has been completed.
Study Purpose: The purpose of this open-label, dose-escalation trial was to evaluate the safety, pharmacokinetics, and antiviral activity of the bNAbs TMB-365 and TMB-380 (also known as VRC07-523LS) in individuals with viral suppression on ART.
Study Population:

  • Participants were adults with asymptomatic HIV who had been on continuous suppressive ART for 6 months prior to screening.
  • Participants had undetectable HIV RNA at screening and one documented result of undetectable HIV RNA within 3 months of screening.
  • Participants had CD4 counts >350 cells/mm3.21,22

Selected Study Results: Results presented at CROI 2025 showed that a single intravenous (IV) infusion of TMB-365 and TMB-380 administered every 8 weeks in participants undergoing an ATI of ART was effective in maintaining viral suppression in 16 out of 17 participants (94%) throughout the 24-week treatment period. The TMB-365 and TMB-380 bNAb combination was generally safe with no serious adverse events (SAEs) or Grade 3 or 4 adverse events (AEs) reported.22
Additional Published Material:

Study Identifiers: ACTG A5357; NCT03739996

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Phase: 2
Status: This study has been completed.
Study Purpose: The purpose of this open-label study was to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of long-acting cabotegravir (CAB LA) plus VRC07-523LS in adults with viral suppression.
Study Population:

  • Participants were adults with HIV who had been on a three-drug ART regimen (a boosted PI, an NNRTI, or an INSTI plus two NRTIs) for at least 8 weeks. Participants had no history of a switch due to virologic failure.
  • Participants had HIV RNA <50 copies/mL at screening and had HIV RNA <50 copies/mL within the 2 years prior to study entry.
  • Participants had CD4 counts ≥350 cells/mm3.
  • Participants had viral sensitivity to VRC07-523LS.23

Selected Study Results: Results published in Clinical Infectious Diseases (2025) and presented at CROI 2024 demonstrated that CAB LA plus VRC07-523LS was safe and capable of maintaining viral suppression in 93% of participants. Eleven participants (15%) had Grade 3 or higher AEs (primarily transient infusion reactions) that were at least possibly related to CAB LA or VRC07-523LS, and one participant discontinued treatment due to a Grade 1 infusion-related reaction. Five out of 71 participants experienced virologic failure (defined as viral load of 200 copies/mL or higher at or prior to Week 44 of Step 2).24,25

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

Sponsor: Gilead Sciences
Phase: 2a
Status: This study has been completed.
Study Purpose: The purpose of this open-label trial was to evaluate the safety and tolerability of the bNAbs VRC07-523LS and CAP256V2LS in combination with the TLR7 agonist vesatolimod in early ART-treated women with clade C HIV.
Study Population:

  • Participants were adult females with HIV who were recruited from the Females Rising through Education, Support, and Health (FRESH) acute HIV infection cohort.
  • Participants had been receiving ART for at least 12 consecutive months prior to screening.
  • Participants had HIV RNA <50 copies/mL at screening and for 12 consecutive months prior to screening.
  • Participants had documented viral sensitivity to VRC07-523LS or CAP256V2LS.26

Selected Study Results: Results presented at CROI 2025 showed that vesatolimod and the bNAbs VRC07-523LS and CAP256V2LS were safe, with no treatment-related SAEs reported. Eighteen participants (90%) experienced infusion-related reactions, all of which were mild to moderate in severity and resolved within 2 days. One participant had a treatment-emergent AE resulting in discontinuation of vesatolimod. During an ATI of ART, varying patterns of viral control were seen among the 20 participants.27
Additional Published Material:

Study Identifiers: A5388; NCT05719441

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Phase: 2
Status: See the ClinicalTrials.gov record for this study's status.
Study Purpose: The purpose of this study is to determine whether administration of the bNAbs VRC07-523LS and PGT121.414.LS in adults who are initiating ART during acute HIV infection is safe and to determine whether this combination strategy can induce HIV remission.
Study Population: The A5388 study is a multi-step trial. Participants in Step 1 are treatment-naive adults with acute HIV infection who are willing to initiate ART at enrollment.28

Study Identifiers: IMPAACT 2042; Tatelo Plus Study; NCT06508749

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Phase: 1/2
Status: This study is currently recruiting participants.
Study Purpose: The purpose of this open-label study is to evaluate the impact of three bNAbs (PGDM1400LS, VRC07-523LS, and PGT121.414.LS) or ATI on viral reservoir, immune function, and maintenance of HIV suppression in early ART-treated children in Botswana.
Study Population:

  • Participants are children and young adults (24 weeks to 25 years of age) with HIV who were previously enrolled in the EIT/Tatelo or Moso Cohort Study.
  • Participants have been receiving ART and have HIV RNA <40 copies/mL.29

Additional studies evaluating VRC07-523LS for HIV treatment have been completed or are being conducted, including the following Phase 1 trials:

  • VOR-07 study (NCT03803605): A trial that evaluated the effects of the latency-reversing agent vorinostat plus VRC07-523LS on persistent HIV infection. This study has been completed, and results are available from IAS 2021 and The Journal of Infectious Diseases (2021).30
  • VRC 607/ACTG A5378 (NCT02840474): A trial that evaluated the safety and antiviral effects of the bNAbs VRC01LS and VRC07-523LS in treatment-naive adults with HIV. This study has been completed, and results are available from IAS 2019 and the Journal of Clinical Investigation Insight (2025).31
  • IAVI T002 (NCT03205917): A study that evaluated the safety, tolerability, pharmacokinetics, and antiviral activity of the bNAbs PGDM1400, PGT121, and VRC07-523LS in adults without HIV and adults with HIV who were not on ART. This study has been completed, and results are available from CROI 2022 and Nature Medicine (2022).32
  • ACTG A5386 (NCT04340596): A trial investigating the safety and efficacy of N-803 (an IL-15 superagonist), administered with and without the bNAbs VRC07-523LS and 10-1074, in controlling viral load during a treatment interruption of ART. This study is ongoing, but not recruiting participants.33
  • RV 630/DELIVER-01 (NCT06484335): A trial evaluating the safety and efficacy of the bNAbs VRC07-523LS and PGDM1400LS in combination with therapeutic HIV vaccines for the induction of HIV remission in adults with HIV who initiated or will initiate ART during the acute stage of infection. See the ClinicalTrials.gov record for this study’s status.34
  • PACTR202309578224660: An open-label study assessing whether the bNAbs CAP256V2LS and VRC07-523LS can control viral load in participants who undergo an ATI of ART. See the Pan African Clinical Trials Registry record for this study’s status.35
  • A5389 (NCT06987318): An open-label study evaluating the effectiveness of VRC07-523LS and PGT121.414.LS in controlling viral load levels during an ATI of ART in adults with HIV who had initiated ART during acute/early infection. See the ClinicalTrials.gov record for this study’s status.36

Adverse Events Adverse Events

Adverse Events

IAVI T003 (NCT03721510)

In this Phase 1/2a trial, three participants without HIV received a single infusion of PGT121 and VRC07-523LS and three other participants without HIV received a single infusion of PGT121, VRC07-523LS, and PGDM1400. Thereafter, 12 participants with HIV received up to six monthly infusions of PGT121, VRC07-523LS, and PGDM1400. All three bNAbs studied were reported to be generally safe and well tolerated. There were four serious adverse events (SAEs) and/or a Grade 3 or higher adverse event (AE), all of which were considered unrelated to the study bNAbs.15,16

NCT04357821

In this Phase 1/2 trial, 10 participants received a combination regimen consisting of therapeutic HIV vaccination (Gag conserved element [CE]-targeted DNA+IL-12 prime/MVA boost vaccination), bNAbs VRC07-523LS and 10-1074, and the TLR9 agonist lefitolimod. Two participants experienced ALT elevations (Grade 3 and 4) which were attributed to external causes rather than to trial interventions.18,19

NCT05275998

In the first part of this Phase 1b/2a dose-escalation trial, safety data from 30 participants who received single infusions of TMB-365 and TMB-380 (VRC07-523LS) indicated that both bNAbs were safe at all three dose levels studied. No SAEs, Grade 3 or 4 AEs, or acute infusion reactions were reported. Twenty-three participants experienced a total of 32 mild or moderate treatment emergent AEs. Five AEs were considered probably or definitely related to bNAb infusions. Two participants in the mid-dose group had a hypersensitivity reaction (delayed onset fatigue and chills) to bNAb infusions. Other bNAb-related AEs included peripheral coldness, fatigue, and sneezing.37

In the second part of this study, 21 participants received at least one infusion of TMB-365 and TMB-380. Two participants discontinued treatment due to a drug-related AE—one participant developed a Grade 2 generalized rash 32 days after the first infusion, and the other participant developed Grade 2 atypical rash 62 days after the first infusion. No SAEs, Grade 3 or 4 AEs, or acute infusion reactions were reported. AEs that were considered possibly or probably related to TMB-365 and TMB-380 occurred in eight participants and included rash, fatigue, headache, flushing, fever, chills, and aches. One participant developed low titer levels of anti-TMB-365 antibody and experienced Grade 1 AEs during the study.22

ACTG A5357 (NCT03739996)

In this Phase 2 trial, 75 participants initially received oral CAB plus two NRTIs for 4 weeks (Step 1). Thereafter, 71 participants who tolerated the oral CAB regimen and maintained viral suppression discontinued oral CAB and NRTIs and switched to intramuscular (IM) CAB LA plus intravenous (IV) VRC07-523LS for up to 48 weeks (Step 2). During Step 2, one participant discontinued treatment due to a Grade 1 infusion reaction that started and resolved on the day of their third VRC07-523LS infusion. Eleven participants (15%) experienced Grade 3 AEs that were considered at least possibly related to CAB LA or VRC07-523LS. Grade 3 AEs that were at least possibly related to VRC07-523LS included chills, feeling unwell, fatigue, generalized aching, vasospasm, hypotension, myalgia, and headache. Grade 3 AEs that were at least possibly related to CAB LA included muscle pain and decreased creatinine clearance. One participant had Grade 3 elevated ALT levels, which was possibly related to both CAB LA and VRC07-523LS. No Grade 4 AEs were reported.24,38

GS-US-382-5445 (NCT05281510)

In this Phase 2a trial, 20 participants received up to 10 oral doses of vesatolimod and IV infusions of the bNAbs VRC07-523LS and CAP256VLS. No treatment-related serious AEs were reported. One participant developed a treatment-emergent AE—Grade 1 cytokine release syndrome—that led to discontinuation of vesatolimod. Eighteen participants (90%) experienced infusion-related reactions, all of which were mild to moderate in severity and resolved within 2 days.27

Drug Interactions Drug Interactions

Drug Interactions

Drug-drug interactions associated with VRC07-523LS are currently unknown.

References References

References

  1. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Accessed July 18, 2025
  2. Treatment Action Group website. Research toward a cure trials. Accessed July 18, 2025
  3. Jefferys R. The HIV vaccines and passive immunization pipeline report 2024. Treatment Action Group Pipeline Report 2024. Accessed July 18, 2025
  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 18, 2025
  5. Julg B, Stephenson KE, Wagh K, et al. Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a Phase 1 clinical trial. Nat Med. 2022;28(6):1288-1296. doi:10.1038/s41591-022-01815-1. Accessed July 18, 2025
  6. Gaudinski MR, Houser KV, Doria-Rose NA, et al. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a Phase 1 dose-escalation clinical trial. Lancet HIV. 2019;6(10):e667-e679. doi:10.1016/S2352-3018(19)30181-X. Accessed July 18, 2025
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  8. Liu Y, Cao W, Sun M, Li T. Broadly neutralizing antibodies for HIV-1: efficacies, challenges and opportunities. Emerg Microbes Infect. 9(1):194-206. doi:10.1080/22221751.2020.1713707. Accessed July 18, 2025
  9. Halper-Stromberg A, Nussenzweig MC. Towards HIV-1 remission: potential roles for broadly neutralizing antibodies. J Clin Invest. 2016;126(2):415-423. doi:10.1172/JCI80561. Accessed July 18, 2025
  10. Bruel T, Guivel-Benhassine F, Amraoui S, et al. Elimination of HIV-1-infected cells by broadly neutralizing antibodies. Nat Commun. 2016;7:10844. Accessed July 18, 2025
  11. Stephenson KE, Barouch DH. Broadly Neutralizing Antibodies for HIV Eradication. Curr HIV/AIDS Rep. 2016;13(1):31-37. doi:doi:10.1007/s11904-016-0299-7. Accessed July 18, 2025
  12. Caskey M Klein F, Lorenzi JC, et al. 3BNC117 a broadly neutralizing antibody suppresses viremia in HIV-1-infected humans. Nature. 2015;522(7557):487-491. Accessed July 18, 2025
  13. National Institute of Allergy and Infectious Diseases (NIAID). A multicenter, randomized, partially blinded 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 and routes to healthy, HIV-uninfected adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on December 21, 2017. NLM Identifier: NCT03387150. Accessed July 18, 2025
  14. Walsh SR, Gay CL, Karuna ST, et al. Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial. PLOS Med. 2024;21(6):e1004329. doi:10.1371/journal.pmed.1004329. Accessed July 18, 2025
  15. 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 18, 2025
  16. 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 18, 2025
  17. 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 18, 2025
  18. 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 18, 2025
  19. 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 18, 2025
  20. 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 18, 2025
  21. TaiMed Biologics Inc. A Phase 1b/2 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 18, 2025
  22. 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 18, 2025
  23. 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 18, 2025
  24. 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 18, 2025
  25. 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. Published online July 15, 2025:ciaf375. doi:10.1093/cid/ciaf375. Accessed July 18, 2025
  26. 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 18, 2025
  27. 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 18, 2025
  28. 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 18, 2025
  29. 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 18, 2025
  30. University of North Carolina, Chapel Hill. IGHID 11802 - Combination therapy with the novel clearance modality (VRC07-523LS) and the latency reversal agent (vorinostat) to reduce the frequency of latent, resting CD4+ T cell infection (the VOR-07 study). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on: January 10, 2019. NLM Identifier: NCT03803605. Accessed July 18, 2025
  31. 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 18, 2025
  32. 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 18, 2025
  33. 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 18, 2025
  34. 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 18, 2025
  35. 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 18, 2025
  36. 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 18, 2025
  37. 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 18, 2025
  38. 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 18, 2025

Last Reviewed: July 18, 2025