P1112 (DAIDS ID 11903): Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, a Potent Anti-HIV Neutralizing Monoclonal Antibody, 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 when given to HIV-1 exposed infants.  VRC01 is a potent anti-HIV neutralizing monoclonal antibody.  The primary objectives of the P1112 are to assess the safety of single subcutaneous dose (20 mg/kg or 40 mg/kg) of VRC01 and to determine pharmacokinetic profile of single dose, subcutaneous VRC01.  The first cohort of 13 infants will receive a single dose of 20 mg/kg of VCR01 SC.  If the mini-cohort of 6 infants in this group pass the Day 28 safety criteria and Cohort 1 has been fully accrued, enrollment into Cohort 2 will begin.  Cohort 2 will receive a single dose of 40 mg/kg of VRC01. 

Study Documents:

Protocol Version 2

Protocol Version 1

1112 study training

Sites where the study is implemented:

CRS ID Site Name City Country

8950

Stellenbosch University

Cape Town

South Africa

3801

Texas Childrens Hosp. CRS

Houston

United States of America

4001

Chicago Children's CRS

Chicago

United States of America

4201

University of Miami Pediatric/Perinatal HIV/AIDS

Miami

United States of America

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5030

Emory University School of Medicine NICHD CRS

Atlanta

United States of America

5031

San Juan City Hospital

San Juan

United States of America

5048

University of Southern California LA

Los Angeles

United States of America

5051

University of Florida Jacksonville

Jacksonville

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5055

South Florida CDTC Ft Lauderdale NICHD CRS

Fort Lauderdale

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

5112

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR

Los Angeles

United States of America

5113

The Children's Hospital of Philadelphia

Philadelphia

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

31890

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

Clinical Trials Specialist: Megan Valentine

Data Manager: Bobbie Graham

Data Manager: Benjamin Johnston

Field Representative: Julieta Giner

Immunologist: Elizabeth (Betsy) McFarland

Investigator: Barney Graham

Investigator: John Mascola

Investigator: Jeffrey Safrit

Laboratory Data Manager (LDM): Christopher Hensel

Laboratory Data Manager (LDM): Kyle Lambert

Laboratory Technologist: Paul Harding

Pharmacologist: Edmund Capparelli

Protocol Pharmacist: Lynette Purdue

Statistician: Leavitt Morrison

Statistician: Petronella Muresan

Virologist: Grace Aldrovandi

Westat Representative: Kathryn Myers

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.