VRC07-523LS

BIOLOGICAL17 trials

Conditions

ARTAcquired Immunodeficiency SyndromeAcute HIV InfectionHIVHIV InfectionHIV InfectionsHIV-1HIV-1 Infection

Phase 1

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infection

Start: 2015-01-23End: 2031-12-31Target: 1120Updated: 2026-04-03

Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

CompletedNCT02256631

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2015-06-30End: 2021-12-16Updated: 2023-02-08

Evaluating 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

CompletedNCT03387150

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2018-02-28End: 2020-12-07Updated: 2023-04-05

Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants

CompletedNCT03735849

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2019-01-18End: 2020-12-21Updated: 2025-06-05

Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons

CompletedNCT03803605

University of North Carolina, Chapel HillHIV-1 Infection

Start: 2019-02-12End: 2021-01-28Updated: 2021-12-02

Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants

CompletedNCT03928821

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2019-07-17End: 2021-03-25Updated: 2022-07-11

Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants

CompletedNCT04212091

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2020-11-10End: 2023-01-18Updated: 2024-12-13

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

Active, not recruitingNCT04340596

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infection

Start: 2021-05-21End: 2026-12-30Updated: 2025-03-25

Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults

Active, not recruitingNCT04983030

Boris Juelg, MD PhDAcquired Immunodeficiency Syndrome, HIV, Immunologic Deficiency Syndrome, Acquired +2

Start: 2022-04-01End: 2026-04-30Target: 36Updated: 2026-01-12

Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission

WithdrawnNCT05769569

Henry M. Jackson Foundation for the Advancement of Military MedicineHIV-1-infection

Start: 2023-09-01End: 2025-07-01Updated: 2024-05-03

10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults

Active, not recruitingNCT05890963

David HoHIV-1-infection

Start: 2023-11-28End: 2027-05-31Updated: 2025-04-25

RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV

RecruitingNCT06484335

Henry M. Jackson Foundation for the Advancement of Military MedicineAcute HIV Infection, ART, HIV Infections +1

Start: 2025-03-27End: 2027-08-01Target: 48Updated: 2025-09-16

The Tatelo Plus Study

RecruitingNCT06508749

National Institute of Allergy and Infectious Diseases (NIAID)HIV, HIV Infections

Start: 2024-11-11End: 2028-04-21Target: 41Updated: 2025-06-10

Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1

RecruitingNCT06517693

National Institute of Allergy and Infectious Diseases (NIAID)HIV-1

Start: 2026-01-05End: 2028-06-30Target: 48Updated: 2026-03-17

A 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

Not yet recruitingNCT06987318

National Institute of Allergy and Infectious Diseases (NIAID)HIV-1-infection

Start: 2026-06-12End: 2028-05-07Target: 40Updated: 2026-04-03

Phase 2

Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

CompletedNCT03739996

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2019-12-31End: 2024-04-29Updated: 2025-05-23

A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

RecruitingNCT05719441

National Institute of Allergy and Infectious Diseases (NIAID)Acute HIV Infection

Start: 2024-08-19End: 2028-09-06Target: 48Updated: 2025-11-18

2025-09-25

Stable Latent HIV Infection and Low-level Viremia Despite Treatment With the Broadly Neutralizing Antibody VRC07-523LS and the Latency Reversal Agent Vorinostat

UNC Libraries2025-09-24

Virologic effects of broadly neutralizing antibodies VRC01LS and VRC07-523LS on chronic HIV-1 infection

JCI Insight2025-02-235 citations

Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial.

2024-12-105 citations

Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial

UNC Libraries2024-07-06

Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial

PLoS Medicine2024-06-249 citations

HIV-1 reservoir size after neonatal antiretroviral therapy and the potential to evaluate antiretroviral-therapy-free remission (IMPAACT P1115): a phase 1/2 proof-of-concept study.

2023-12-0410 citations

Safety, tolerability, pharmacokinetics, and immunological activity of dual-combinations and triple-combinations of anti-HIV monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered intravenously to HIV-uninfected adults: a phase 1 randomised trial.

2023-10-0126 citations

Infants Receiving Very Early Antiretroviral Therapy Have High CD4 Counts in the First Year of Life

Clinical Infectious Diseases2022-08-295 citations

Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial.

2022-05-12112 citations

Stable Latent HIV Infection and Low-level Viremia Despite Treatment With the Broadly Neutralizing Antibody VRC07-523LS and the Latency Reversal Agent Vorinostat

The Journal of Infectious Diseases2021-09-2148 citations

Pharmacokinetics and safety of early nevirapine-based antiretroviral therapy for neonates at high risk for perinatal HIV infection: a phase 1/2 proof of concept study.

2020-11-2312 citations

Broadening community engagement in clinical research: Designing and assessing a pilot crowdsourcing project to obtain community feedback on an HIV clinical trial

Clinical Trials2020-02-0320 citations

The Mission is Remission

The Pediatric Infectious Disease Journal2018-10-222 citations

Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults

PLoS Medicine2018-01-24249 citations

VRC07-523LS

Sponsors

Conditions

Phase 1

Phase 2

Related Papers