MedPath

VRC-07-523

Generic Name
VRC-07-523

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

Phase 1
Not yet recruiting
Conditions
HIV-1
Interventions
First Posted Date
2024-07-24
Last Posted Date
2025-01-30
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
48
Registration Number
NCT06517693
Locations
🇵🇷

Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research, San Juan, Puerto Rico

🇺🇸

Site 5030, Emory University School of Medicine, Atlanta, Georgia, United States

🇺🇸

Site 5112, David Geffen School of Medicine at UCLA, Los Angeles, California, United States

and more 13 locations

The Tatelo Plus Study

Phase 1
Recruiting
Conditions
HIV
HIV Infections
Interventions
Other: Analytic Treatment Interruption
Drug: ART Regimen prior to enrolling in Step 1a
Drug: ART Regimen prior to enrolling in Step 1b
First Posted Date
2024-07-18
Last Posted Date
2024-11-20
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
41
Registration Number
NCT06508749
Locations
🇧🇼

Francistown CRS (CRS #31891), Francistown, Botswana

🇧🇼

Botswana Harvard Health Partnership CRS (CRS #31833), Gaborone, Botswana

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

Phase 1
Not yet recruiting
Conditions
Acute HIV Infection
HIV Infections
PLWH
ART
Interventions
Biological: VRC07-523LS
Biological: PGDM1400LS
Other: Placebo
Biological: ChAdOx1.tHIVconsv1
Biological: ChAdOx1.HIVconsv62
Biological: MVA.tHIVconsv4
Biological: A244d11 gp120
Biological: ALFQ
First Posted Date
2024-07-03
Last Posted Date
2025-03-17
Lead Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Target Recruit Count
48
Registration Number
NCT06484335
Locations
🇹🇭

The Faculty of Medicine, Chulalongkorn University/ King Chulalongkorn Memorial Hospital, Pathum Wan, Bangkok, Thailand

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

Phase 1
Active, not recruiting
Conditions
HIV-1-infection
Interventions
Drug: ART
Drug: 10E8.4/iMab
First Posted Date
2023-06-06
Last Posted Date
2025-04-25
Lead Sponsor
David Ho
Target Recruit Count
20
Registration Number
NCT05890963
Locations
🇹🇿

National Institute for Medical Research-Mbeya Medical Resarch Center, Mbeya, Tanzania

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

Phase 2
Suspended
Conditions
Acute HIV Infection
Interventions
First Posted Date
2023-02-09
Last Posted Date
2025-04-23
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
48
Registration Number
NCT05719441
Locations
🇺🇸

31788, Alabama CRS, Birmingham, Alabama, United States

🇺🇸

1201, University of Southern California CRS, Los Angeles, California, United States

🇺🇸

601, University of California, Los Angeles CARE Center CRS, Los Angeles, California, United States

and more 33 locations

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

Phase 1
Active, not recruiting
Conditions
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndrome, Acquired
HIV
Sexually Transmitted Diseases, Viral
Retroviridae Infections
Interventions
First Posted Date
2021-07-30
Last Posted Date
2025-02-05
Lead Sponsor
Boris Juelg, MD PhD
Target Recruit Count
36
Registration Number
NCT04983030
Locations
🇺🇸

UCLA CARE (Center for AIDs Research and Education), Los Angeles, California, United States

🇺🇸

Orlando Immunology Center, Orlando, Florida, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 3 locations

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

Phase 1
Active, not recruiting
Conditions
HIV Infection
Interventions
Biological: N-803 (IL-15 Superagonist)
First Posted Date
2020-04-09
Last Posted Date
2025-03-25
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
118
Registration Number
NCT04340596
Locations
🇺🇸

New Jersey Medical School Clinical Research Center CRS [Site ID: 31786], Newark, New Jersey, United States

🇺🇸

Columbia P&S CRS, New York, New York, United States

🇺🇸

Weill Cornell Uptown CRS (Site ID: 7803), New York, New York, United States

and more 11 locations

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

Phase 1
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2019-12-26
Last Posted Date
2024-12-13
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
33
Registration Number
NCT04212091
Locations
🇺🇸

George Washington Univ. CRS, Washington, District of Columbia, United States

🇺🇸

Columbia P&S CRS, New York, New York, United States

🇺🇸

The Hope Clinic of the Emory Vaccine Center CRS, Decatur, Georgia, United States

and more 2 locations

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

Phase 2
Completed
Conditions
HIV Infections
Interventions
Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Drug: Standard of Care (SOC) Oral ART
First Posted Date
2018-11-14
Last Posted Date
2024-11-22
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
75
Registration Number
NCT03739996
Locations
🇺🇸

Johns Hopkins University CRS, Baltimore, Maryland, United States

🇵🇷

Puerto Rico AIDS Clinical Trials Unit CRS, San Juan, Puerto Rico

🇺🇸

UCSD Antiviral Research Center CRS, San Diego, California, United States

and more 16 locations

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

Phase 1
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2018-11-08
Last Posted Date
2025-05-15
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
28
Registration Number
NCT03735849
Locations
🇺🇸

Brigham and Women's Hospital Vaccine CRS (BWH VCRS), Boston, Massachusetts, United States

🇺🇸

Seattle Vaccine and Prevention CRS, Seattle, Washington, United States

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