FindTrial
Sign In

VRC01

BIOLOGICAL11 trials

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions

HIV InfectionHIV Infections

Phase 1

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
RecruitingNCT02140255
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 Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults
CompletedNCT02165267
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2014-08-31End: 2016-02-29Updated: 2021-10-15
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, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)
CompletedNCT02411539
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2015-08-25End: 2016-09-29Updated: 2021-11-05
Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption
CompletedNCT02463227
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2015-08-31End: 2016-10-31Updated: 2021-10-19
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
Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults
CompletedNCT02797171
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2017-03-01End: 2019-06-05Updated: 2024-03-20
Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
CompletedNCT03208231
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2018-08-06End: 2021-02-11Updated: 2023-05-24

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
ART-free HIV-1 remission in children with in-utero HIV-1 after very early ART (IMPAACT P1115): a multicentre, open-label, phase 1/2 proof-of-concept study.
2025-09-25
Virologic effects of broadly neutralizing antibodies VRC01LS and VRC07-523LS on chronic HIV-1 infection
JCI Insight2025-02-235 citations
High monoclonal neutralization titers reduced breakthrough HIV-1 viral loads in the Antibody Mediated Prevention trials.
2023-12-1420 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
Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01.
2023-11-284 citations
Infants Receiving Very Early Antiretroviral Therapy Have High CD4 Counts in the First Year of Life
Clinical Infectious Diseases2022-08-295 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
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
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
The Mission is Remission
The Pediatric Infectious Disease Journal2018-10-222 citations
Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART
Open Forum Infectious Diseases2018-10-0133 citations
HIV-1 latent reservoir size and diversity are stable following brief treatment interruption
Journal of Clinical Investigation2018-06-17110 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
Population pharmacokinetics analysis of VRC01, an HIV-1 broadly neutralizing monoclonal antibody, in healthy adults
mAbs2017-04-0351 citations
Effect of HIV Antibody VRC01 on Viral Rebound after Treatment Interruption
New England Journal of Medicine2016-11-09463 citations