P1110 (DAIDS ID 11891): A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-Exposed Infants at High Risk

Study Status Study Restriction

Enrolling

US & Non-US

What is P1110?

P1110 is a Phase I, open label, non-comparative dose-finding study of HIV-1 exposed full-term neonates (aged ≤48 hours) assessed as high risk of acquiring HIV-1 infection and their mothers.  The study is designed to evaluate the safety and tolerability through 6 weeks of life of raltegravir oral granules for suspension when administered during the first 6 weeks of life with standard PMTCT ARV prophylaxis to HIV-1 exposed infants assessed at high risk of HIV infection.

Study Documents:

Study Training Materials

Sites where the study is implemented:

CRS ID Site Name City Country

5082

Hospital General de Agudos Buenos Aires Argentina NICHD CRS

Buenos Aires

Argentina

5072

Hospital dos Servidores Rio de Janeiro

Rio de Janeiro

Brazil

5073

SOM Federal University Minas Gerais Brazil

Minas Gerais

Brazil

5074

Univ of Sao Paulo Brazil

Sao Paulo

Brazil

5097

Hosp. Geral De Nova Iguacu Brazil NICHD CRS

Rio de Janeiro, Rio de Janeiro

Brazil

5117

Hospital Nossa Senhora da Conceicao CRS

Porto Alegre

Brazil

8950

Stellenbosch University

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

4001

Chicago Children's CRS

Chicago

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

5017

Univ of Washington Children's Hospital Seattle

Seattle

United States of America

5029

Univ of Washington NICHD CRS

Seattle

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

5040

SUNY Stony Brook

Stony Brook

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

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

Study contacts:

Study Chair: Diana Clarke

Study Vice-Chair: Yvonne Bryson

Study Vice-Chair: Mark Mirochnick

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Katherine Calabrese

DAIDS Clinical Representative: Ellen DeCarlo

Data Manager: Bobbie Graham

Data Manager: Stephanie Popson

Drug Co. Representative: Hedy Teppler

Laboratory Data Manager (LDM): Oswald Dadson

Laboratory Specialist: Diane Costello

Laboratory Technologist: Patricia Anthony

Pharmacologist: Edward Acosta

Protocol Pharmacist: Nayri  Khairalla

Senior Statistician: Terence Fenton

Statistician: Mae Cababasay

Statistician: Jiajia Wang

Virologist: Deborah Persaud

Virologist: Stephen Spector

Westat Representative: Kathryn Myers

Westat Representative: Rita Patel

 

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.