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

PHASE1CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

June 17, 2020

Study Completion Date

December 16, 2021

Conditions
HIV Infections
Interventions
BIOLOGICAL

VRC01

Administered by subcutaneous injection in the thigh

BIOLOGICAL

VRC01LS

Administered by subcutaneous injection in the thigh

BIOLOGICAL

VRC07-523LS

Administered by subcutaneous injection in the thigh

Trial Locations (14)

7505

Famcru Crs, Tygerberg

10457

Bronx-Lebanon Hospital Center NICHD CRS, The Bronx

10461

Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx

21287

Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore

30322

Emory University School of Medicine NICHD CRS, Atlanta

32209

Univ. of Florida Jacksonville NICHD CRS, Jacksonville

33136

Pediatric Perinatal HIV Clinical Trials Unit CRS, Miami

33316

South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale

80045

Univ. of Colorado Denver NICHD CRS, Aurora

90095-1752

David Geffen School of Medicine at UCLA NICHD CRS, Los Angeles

77030-2399

Texas Children's Hospital CRS, Houston

00936

San Juan City Hosp. PR NICHD CRS, San Juan

00935

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS, San Juan

Unknown

Harare Family Care CRS, Harare

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02256631 - Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants | Biotech Hunter | Biotech Hunter