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Showing 1–24 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: VRC07-523LS Clear all
Completed Phase 1 Interventional Results available

Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults

NCT02840474
View directory record Official record
Conditions
HIV-1
Interventions
VRC-HIVMAB080-00-AB, VRC-HIVMAB075-00-AB
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 70 Years
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
6
States / cities
Birmingham, Alabama • Los Angeles, California • St Louis, Missouri + 3 more
Source: ClinicalTrials.gov public record
Updated Jan 29, 2025 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 2 Interventional Results available

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

NCT03739996
View directory record Official record
Conditions
HIV Infections
Interventions
Oral Cabotegravir (CAB), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Long-Acting Injectable Cabotegravir (CAB LA), VRC07-523LS, Standard of Care (SOC) ART
Drug · Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
17
States / cities
Birmingham, Alabama • San Diego, California • San Francisco, California + 12 more
Source: ClinicalTrials.gov public record
Updated May 22, 2025 · Synced Sep 3, 2026, 5:35 AM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers Results available

Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults

NCT03565315
View directory record Official record
Conditions
Healthy Adult Immune Response
Interventions
VRC-HIVMAB095-00-AB (10E8VLS), VRC-HIVMAB075-00-AB (VRC07-523LS)
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 60 Years
Enrollment
9 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2019
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Dec 29, 2020 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

NCT05184452
View directory record Official record
Conditions
HIV Infections
Interventions
PGDM1400LS (5mg/kg, IV), PGDM1400LS (20mg/kg, IV), PGDM1400LS (20mg/kg, SC), PGDM1400LS (40mg/kg, IV), PGDM1400LS (40mg/kg, SC), PGDM1400LS (1.4g, IV), PGDM1400LS (1.4g, SC), VRC07-523LS (20mg/kg, IV), VRC07-523LS (20mg/kg, SC), VRC07-523LS (1.4g, IV), VRC07-523LS (1.4g, SC), VRC07-523LS (40mg/kg, IV), PGT121.414.LS (20mg/kg, IV), PGT121.414.LS (20mg/kg, SC), PGT121.414.LS (1.4g, IV), PGT121.414.LS (1.4g, SC), PGT121.414.LS (40mg/kg, IV)
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
95 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2023
U.S. locations
5
States / cities
San Francisco, California • Washington D.C., District of Columbia • Atlanta, Georgia + 2 more
Source: ClinicalTrials.gov public record
Updated Feb 9, 2025 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

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

NCT03928821
View directory record Official record
Conditions
HIV Infections
Interventions
PGT121, PGDM1400, 10-1074, VRC07-523LS
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
27 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2021
U.S. locations
4
States / cities
Boston, Massachusetts • New York, New York • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jul 10, 2022 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults

NCT03205917
View directory record Official record
Conditions
HIV Infections
Interventions
PGDM1400/Placebo (3mg/kg IV), PGDM1400/Placebo (10mg/kg IV), PGDM1400/Placebo (30mg/kg IV), PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV), PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV), PGDM1400 + PGT121/Placebo (30mg/kg + 30mg/kg IV), PGDM1400 + PGT121 + VRC07-523LS (20mg/kg + 20mg/kg + 20 mg/kg IV), PGDM1400 + PGT121 (MTD IV)
Biological
Lead sponsor
International AIDS Vaccine Initiative
Network
Eligibility
18 Years to 65 Years
Enrollment
29 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2020
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 13, 2020 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Combinatorial Therapy to Induce an HIV Remission

NCT04357821
View directory record Official record
Conditions
HIV/AIDS
Interventions
Combination Intervention
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years to 67 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Aug 27, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Results available

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

NCT03803605
View directory record Official record
Conditions
HIV-1 Infection
Interventions
VRC07-523LS, Vorinostat (VOR)
Biological · Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 64 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 1, 2021 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Results available

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

NCT02256631
View directory record Official record
Conditions
HIV Infections
Interventions
VRC01, VRC01LS, VRC07-523LS
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
0 Days to 5 Days
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
10
States / cities
Los Angeles, California • Aurora, Colorado • Fort Lauderdale, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 7, 2023 · Synced Sep 3, 2026, 5:35 AM EDT
Active, not recruiting Phase 2 Interventional

HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study

NCT07215468
View directory record Official record
Conditions
HIV -1 Infection
Interventions
TMB-365, TMB-380, Baseline ART
Drug
Lead sponsor
TaiMed Biologics Inc.
Industry
Eligibility
18 Years and older
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
10
States / cities
San Francisco, California • Fort Lauderdale, Florida • Ft. Pierce, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Not yet recruiting Phase 1 Interventional

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

NCT06987318
View directory record Official record
Conditions
HIV-1-infection
Interventions
VRC07-523LS, PGT121.414.LS
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 70 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
10
States / cities
Birmingham, Alabama • San Diego, California • Aurora, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

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

NCT03387150
View directory record Official record
Conditions
HIV Infections
Interventions
VRC07-523LS, Placebo
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
124 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2020
U.S. locations
6
States / cities
Birmingham, Alabama • Atlanta, Georgia • Boston, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated Apr 4, 2023 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers

A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults

NCT03721510
View directory record Official record
Conditions
HIV/AIDS
Interventions
PGT121 + VRC07-523LS, PGT121 + VRC07-523LS + PGDM1400
Biological
Lead sponsor
International AIDS Vaccine Initiative
Network
Eligibility
18 Years to 65 Years
Enrollment
19 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2022
U.S. locations
3
States / cities
Orlando, Florida • Boston, Massachusetts • Houston, Texas
Source: ClinicalTrials.gov public record
Updated May 9, 2022 · Synced Sep 3, 2026, 5:35 AM EDT
Active, not recruiting Phase 1 Interventional

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

NCT04340596
View directory record Official record
Conditions
HIV Infection
Interventions
N-803 (IL-15 Superagonist), VRC07-523LS, 10-1074
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
14
States / cities
Birmingham, Alabama • Los Angeles, California • San Diego, California + 10 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

NCT06812494
View directory record Official record
Conditions
HIV
Interventions
VRC07-523LS 400mg, PGT121.414.LS 400mg, PGDM1400LS 400mg, VRC07-523LS 3200mg, PGT121.414.LS 1600mg, PGDM1400LS 1600mg
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
200 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2027
U.S. locations
13
States / cities
Birmingham, Alabama • San Francisco, California • Decatur, Georgia + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

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

NCT04212091
View directory record Official record
Conditions
HIV Infections
Interventions
PGT121.414.LS, VRC07-523LS
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
33 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
5
States / cities
Los Angeles, California • Washington D.C., District of Columbia • Decatur, Georgia + 2 more
Source: ClinicalTrials.gov public record
Updated Dec 12, 2024 · Synced Sep 3, 2026, 5:35 AM EDT
Recruiting Phase 2 Interventional

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

NCT05719441
View directory record Official record
Conditions
Acute HIV Infection
Interventions
VRC07-523LS, PGT121.414.LS, Placebo, ART
Biological · Other · Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 70 Years
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
32
States / cities
Birmingham, Alabama • Los Angeles, California • San Diego, California + 24 more
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Results available

VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults

NCT03015181
View directory record Official record
Conditions
HIV Prevention
Interventions
VRC-HIVMAB075-00-AB
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 25, 2020 · Synced Sep 3, 2026, 5:35 AM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

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

NCT06517693
View directory record Official record
Conditions
HIV-1
Interventions
PGT121.414.LS, VRC07-523LS
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
Up to 72 Hours
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2028
U.S. locations
11
States / cities
Los Angeles, California • Aurora, Colorado • Jacksonville, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 24, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Withdrawn Phase 1Phase 2 Interventional

N-803 Combined With the Broadly Neutralizing Antibodies Plus or Minus haNK Cells for HIV

NCT04144335
View directory record Official record
Conditions
Hiv, HIV/AIDS, HIV Infections, AIDS, AIDS and Infections, Aids/Hiv Problem
Interventions
N-803 and bNAbs, haNK™ Cells
Biological
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
3
States / cities
San Francisco, California • Boston, Massachusetts • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 21, 2020 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

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

NCT03735849
View directory record Official record
Conditions
HIV Infections
Interventions
VRC07-523LS
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 50 Years
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2020
U.S. locations
2
States / cities
Boston, Massachusetts • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Jun 4, 2025 · Synced Sep 3, 2026, 5:35 AM EDT
Recruiting Phase 1Phase 2 Interventional

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

NCT02140255
View directory record Official record
Conditions
HIV Infection
Interventions
Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r), Raltegravir (RAL), VRC01, Dolutegravir (DTG), VRC07-523LS
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
Up to 48 Hours
Enrollment
1,120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2031
U.S. locations
20
States / cities
La Jolla, California • Los Angeles, California • Aurora, Colorado + 13 more
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Completed Phase 1Phase 2 Interventional

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

NCT04983030
View directory record Official record
Conditions
HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired, Sexually Transmitted Diseases, Viral, Retroviridae Infections
Interventions
Ad26.Mos4.HIV, MVA-BN-HIV, PGT121, PGDM1400, VRC07-523LS
Biological
Lead sponsor
Boris Juelg, MD PhD
Other
Eligibility
18 Years to 70 Years
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
6
States / cities
Los Angeles, California • Orlando, Florida • Boston, Massachusetts + 3 more
Source: ClinicalTrials.gov public record
Updated May 28, 2026 · Synced Sep 3, 2026, 5:35 AM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1

NCT07390955
View directory record Official record
Conditions
HIV
Interventions
ePGT121v1-LS (IV), PGDM1400LS (IV), VRC07-523LS (IV), ePGT121v1-LS (SC), PGDM1400LS (SC), VRC07-523LS (SC)
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 55 Years
Enrollment
83 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2027
U.S. locations
7
States / cities
Birmingham, Alabama • San Francisco, California • Atlanta, Georgia + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 3, 2026, 5:35 AM EDT