PGT121.414.LS

BIOLOGICAL6 trials

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID), HIV Vaccine Trials Network

Conditions

Acute HIV InfectionHIVHIV InfectionsHIV-1HIV-1-infection

Phase 1

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

Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants

SuspendedNCT05959707

HIV Vaccine Trials NetworkHIV Infections

Start: 2024-08-14End: 2025-01-14Target: 77Updated: 2024-07-05

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

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

Related Papers

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

PLoS Medicine2024-06-249 citations