Drug Database: VRC07-523LS

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.^4–7

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.^7–10 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.^8,11

VRC07-523LS is being studied for HIV prevention and is also being developed as a possible component to HIV treatment or cure.^2,3

Half-life (T_½)

In a Phase 1 study (NCT03387150) of VRC07-523LS administered via different routes and doses in healthy adults without HIV, the estimated median half-life of VRC07-523LS was approximately 40 days.^12,13

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.^14,15

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/mm³.¹⁴

Selected Study Results: Results 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, 36% of the participants who completed follow-up had viral suppression through the end of the study (Week 44).¹⁵

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 of ART. 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.^16,17

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.¹⁷

Study Identifier: NCT04983030

Sponsor: Boris Juelg, MD PhD
Phase: 1/2a 
Status: This study is currently 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.¹⁸

Study Identifier: NCT05275998

Sponsor: TaiMed Biologics Inc.
Phase: 1b/2a 
Status: This study is ongoing, but not recruiting participants. 
Study Purpose: The purpose of this open-label, dose-escalation trial is to evaluate the safety, pharmacokinetics, and antiviral activity of the antibodies TMB-365 and TMB-380 (VRC07-523LS) in individuals with viral suppression on ART.
Study Population:

• Participants are adults with asymptomatic HIV who have been on continuous suppressive ART for 6 months prior to screening.
• Participants have undetectable HIV RNA at screening and one documented result of undetectable HIV RNA within 3 months of screening.
• Participants have CD4 counts >350 cells/mm³.^19,20

Selected Study Results: Available safety and PK results presented at CROI 2024 showed that a single intravenous (IV) infusion of TMB-365 and TMB-380, administered at three different dose levels, was generally safe with no serious adverse events (SAEs) or Grade 3 or 4 adverse events (AEs) reported. Pharmacokinetic data demonstrated the feasibility of an every 8-week dosing schedule, which investigators will evaluate in the Phase 2a portion of the trial.²⁰

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 were clinically stable for at least 8 weeks prior to study entry on a three-drug ART regimen (a boosted PI, an NNRTI, or an INSTI plus two NRTIs). 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 at least two documented results of HIV RNA <50 copies/mL within 12 months of study entry.
• Participants had CD4 counts ≥350 cells/mm³ at screening.
• Participants had viral sensitivity to VRC07-523LS.²¹

Selected Study Results: Results presented at CROI 2024 demonstrated that CAB LA plus VRC07-523LS was safe and capable of maintaining viral suppression in most participants. Eleven (15%) participants had a Grade 3 or higher AE that was 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).²²

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

Sponsor: Gilead Sciences
Phase: 2a 
Status: This study is ongoing, but not recruiting participants. 
Study Purpose: The purpose of this open-label trial is to evaluate the safety and tolerability of the bNAbs VRC07-523LS and CAP256V2LS with the TLR7 agonist vesatolimod in early ART-treated women with clade C HIV.
Study Population:

• Participants are adult females with HIV who are recruited from the Females Rising through Education, Support, and Health (FRESH) acute HIV infection cohort. 
• Participants have been receiving ART for at least 12 consecutive months prior to screening.
• Participants have HIV RNA <50 copies/mL at screening and have had HIV RNA <50 copies/mL for 12 consecutive months prior to screening.
• Participants have documented viral sensitivity to VRC07-523LS or CAP256V2LS.²³

Study Identifiers: A5388; NCT05719441

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Phase: 2 
Status: This study is currently recruiting participants.
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.²⁴

Study Identifiers: IMPAACT 2042; Tatelo Plus Study; NCT06508749

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Phase: 1/2
Status: See the ClinicalTrials.gov record for this study’s status. 
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.²⁵

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

• VOR-07 study (NCT03803605): A Phase 1 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 (2022).²⁶
• VRC 607/ACTG A5378 (NCT02840474): A Phase 1 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 2019.²⁷
• IAVI T002 (NCT03205917): A Phase 1 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).²⁸
• ACTG A5386 (NCT04340596): A Phase 1 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 currently recruiting participants.²⁹
• RV 630/DELIVER-01 (NCT06484335): A Phase 1 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 ART during the acute stage of infection. See the ClinicalTrials.gov record for this study’s status.³⁰
• PACTR202309578224660: A Phase 1 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.³¹

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.^14,15

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.^16,17

NCT05275998

In this Phase 1b/2a dose-escalation trial, early 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.²⁰

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 (15%) participants 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.^22,32

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 August 29, 2024
2. Treatment Action Group website. Research toward a cure trials. Accessed August 29, 2024
3. Jefferys R. The HIV vaccines and passive immunization pipeline report 2024. Treatment Action Group Pipeline Report 2024. Accessed August 29, 2024
4. 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 August 29, 2024
5. 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 August 29, 2024
6. Rudicell RS, Kwon YD, Ko SY, et al. Enhanced Potency of a broadly neutralizing HIV-1 antibody in vitro improves protection against lentiviral infection in vivo. J Virol. 2014;88(21):12669-12682. doi:10.1128/JVI.02213-14. Accessed August 29, 2024
7. 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 August 29, 2024
8. 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 August 29, 2024
9. 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 August 29, 2024
10. 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 August 29, 2024
11. 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 August 29, 2024
12. 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 August 29, 2024
13. Walsh S, Gay C, Karuna S, et al. Safety and single-dose pharmacokinetics of VRC07-523LS administered via different routes and doses. Abstract presented at: HIV Research for Prevention Conference (HIVR4P); January 27-28 and February 3-4, 2021; Virtual. Abstract OA03.01. Accessed August 29, 2024
14. 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 August 29, 2024
15. 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 August 29, 2024
16. 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 August 29, 2024
17. 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 August 29, 2024
18. 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 August 29, 2024
19. 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 August 29, 2024
20. 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 August 29, 2024
21. 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 August 29, 2024
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 August 29, 2024
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 August 29, 2024
24. 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 August 29, 2024
25. 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 August 29, 2024
26. 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 August 29, 2024
27. 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 August 29, 2024
28. 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 August 29, 2024
29. 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 August 29, 2024
30. 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 August 29, 2024
31. 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 August 29, 2024
32. 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 August 29, 2024