P1097 (DAIDS ID 11790): Raltegravir Pharmacokinetics and Safety in Neonates

Study Status Study Restriction

Enrolling

United States

What is P1097?

P1097 is a Phase 0, multi-center washout pharmacokinetic trial of raltegravir in infants born to HIV-infected pregnant women. The study is designed to determine the washout pharmacokinetics and safety of in utero/intrapartum exposure following the infants for up to 20 weeks after birth.

Study Documents:

Training Materials

Sites where the study is implemented:

CRS ID Site Name City Country

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

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Muang

Thailand

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

5017

Univ of Washington Children's Hospital Seattle

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

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

5112

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

Los Angeles

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

Study contacts:

Study Chair: Diana Clarke

Study Vice-Chair: Yvonne Bryson

Study Vice-Chair: Mark Mirochnick

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

Medical Officer: Elizabeth (Betsy) Smith

Pharmacologist: Edward Acosta

Senior Statistician: Terence Fenton

Statistician: Mae Cababasay

Virologist: Deborah Persaud

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.