Placebo for VRC01

BIOLOGICAL4 trials

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions

HIV Infections

Phase 1

Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection

CompletedNCT02591420

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

Start: 2016-04-30End: 2021-03-15Updated: 2025-12-17

Phase 2

Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women

CompletedNCT02568215

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

Start: 2016-05-31End: 2021-03-03Updated: 2022-02-23

Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection

CompletedNCT02664415

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

Start: 2016-08-31End: 2017-08-04Updated: 2021-11-02

Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men

CompletedNCT02716675

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

Start: 2016-04-06End: 2020-12-01Updated: 2022-02-23

Related Papers

Influence of the broadly neutralizing antibody VRC01 on HIV breakthrough virus populations in antibody-mediated prevention trials

Nature Communications2026-04-03

High monoclonal neutralization titers reduced breakthrough HIV-1 viral loads in the Antibody Mediated Prevention trials.

2023-12-1420 citations

Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01.

2023-11-284 citations

Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa.

2021-12-113 citations

Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition

New England Journal of Medicine2021-03-17491 citations

Safety, pharmacokinetics, and immunogenicity of the combination of the broadly neutralizing anti-HIV-1 antibodies 3BNC117 and 10-1074 in healthy adults: A randomized, phase 1 study.

2019-08-0871 citations

Assessing the safety and pharmacokinetics of the monoclonal antibodies, VRC07-523LS and PGT121 in HIV negative women in South Africa: study protocol for the CAPRISA 012A randomised controlled phase I trial

BMJ Open2019-07-0116 citations

Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial.

2019-04-1581 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

Safety, pharmacokinetics, and immunological activities of multiple intravenous or subcutaneous doses of an anti-HIV monoclonal antibody, VRC01, administered to HIV-uninfected adults: Results of a phase 1 randomized trial

PLoS Medicine2017-11-14129 citations