P1112 (DAIDS ID 11903): Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
| Study Status | Study Restriction |
|---|---|
Enrolling |
US & Non-US |
What is P1112?
IMPAACT P1112 is an open-label, dose-escalating, phase I multicenter trial to determine the safety and pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS when given to HIV-1 exposed infants. VRC01, VRC01LS, and VRC07-523LS are potent anti-HIV neutralizing monoclonal antibodies. The primary objectives of P1112 are to assess the safety and pharmacokinetic profiles of VRC01 (single dose for Dose Groups 1 and 2; monthly doses for Dose Group 3), VRC01LS (one or two doses for Dose Group 4) and VRC07-523LS (one or two doses for Dose Group 5), all administered subcutaneously.
Study Documents:
Protocol Version 4
P1112 Summary of Changes from V3.0 to V4.0 – 6 November 2018
P1112 Protocol V4.0 ICFs only – 6 November 2018 (Word version)
Protocol Version 3
Protocol Version 2
Protocol Version 1
Sites where the study is implemented:
| CRS ID | Site Name | City | Country |
|---|---|---|---|
Family Clinical Research Unit (FAM-CRU) CRS |
Cape Town |
South Africa |
|
Texas Childrens Hosp. CRS |
Houston |
United States of America |
|
Chicago Children's CRS |
Chicago |
United States of America |
|
University of Miami Pediatric/Perinatal HIV/AIDS |
Miami |
United States of America |
|
UCSD Mother-Child-Adolescent HIV Program |
San Diego |
United States of America |
|
Boston Medical Center Pediatric HIV Program |
Boston |
United States of America |
|
Jacobi Medical Center Bronx |
Bronx |
United States of America |
|
Emory University School of Medicine NICHD CRS |
Atlanta |
United States of America |
|
San Juan City Hospital |
San Juan |
United States of America |
|
University of Southern California LA |
Los Angeles |
United States of America |
|
University of Florida Jacksonville |
Jacksonville |
United States of America |
|
University of Colorado Denver NICHD CRS |
Aurora |
United States of America |
|
South Florida CDTC Ft Lauderdale NICHD CRS |
Fort Lauderdale |
United States of America |
|
Johns Hopkins University, Baltimore |
Baltimore |
United States of America |
|
UCLA - David Geffen School of Medicine |
Los Angeles |
United States of America |
|
Bronx-Lebanon Hospital IMPAACT |
Bronx |
United States of America |
|
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS |
San Juan |
United States of America |
|
Harare Family Care CRS |
Harare |
Zimbabwe |
Study contacts:
Study Chair: Coleen Cunningham |
Study Vice-Chair: Elizabeth (Betsy) McFarland |
DAIDS Medical Officer: Elizabeth (Betsy) Smith |
NICHD Medical Officer: Rohan Hazra |
Clinical Trials Specialist: Charlotte Perlowski |
Data Manager: Benjamin Johnston |
Data Manager: Bonnie Zimmer |
ICAB Representative: Maximina Jokonya |
ICAB Representative: Alejandro Reyes Santos |
Immunologist: Elizabeth (Betsy) McFarland |
Investigator: Barney Graham |
Investigator: John Mascola |
Investigator: Jeffrey Safrit |
Laboratory Data Manager (LDM): Frederic Bone |
Laboratory Specialist: Nicole Tobin |
Laboratory Technologist: Paul Harding |
Pharmacologist: Edmund Capparelli |
Protocol Pharmacist: Lynette Purdue |
Statistician: Petronella Muresan |
Virologist: Grace Aldrovandi |
Westat Representative: Kathryn Myers |