Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Completed · Phase 1
Conditions studied: HIV Infections
In brief
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
Key facts
- Study ID
- NCT02256631
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 83
- Starts
- 2015-06-30
- Expected to finish
- 2021-12-16
- Last updated by the study team
- 2023-02-08
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
Where it is running
- David Geffen School of Medicine at UCLA NICHD CRS — Los Angeles, California, United States
- Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
- South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
- Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
- Pediatric Perinatal HIV Clinical Trials Unit CRS — Miami, Florida, United States
- Emory University School of Medicine NICHD CRS — Atlanta, Georgia, United States
- Johns Hopkins Univ. Baltimore NICHD CRS — Baltimore, Maryland, United States
- Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States
- Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
- Texas Children's Hospital CRS — Houston, Texas, United States
- San Juan City Hosp. PR NICHD CRS — San Juan, PR, Puerto Rico
- University of Puerto Rico Pediatric HIV/AIDS Research Program CRS — San Juan, Puerto Rico
- Famcru Crs — Tygerberg, Western Cape, South Africa
- Harare Family Care CRS — Harare, Zimbabwe
Full record on ClinicalTrials.gov
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