P1115 (DAIDS ID 11954): Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study
Study Status | Study Restriction |
---|---|
Enrolling |
US & Non-US |
What is P1115?
P1115 is a Phase I/II, multi-center, proof-of-concept study that will explore the effects of early intensive antiretroviral therapy on achieving HIV remission in neonates. The study will also assess the safety and pharmacokinetics of early intensive antiretroviral therapy in neonates.
Study documents:
Protocol Version 2.0-
P1115 Summary of Changes from V1 to V2 in Portuguese – 17 September 2018
- Cross-Network PBMC Processing Standard Operating Procedure
- ACCUSPIN System-Histopaque®-1077 Product Information
- Histopaque® Troubleshooting Guide
-
ISENTRESS (raltegravir) for Oral Suspension - Instructions for Use for Babies and Toddlers
» Study Trainings
» Other Study Implementation Documents
Sites where the study is implemented:
CRS ID | Site Name | City | Country |
---|---|---|---|
Inst of Pediatrics Fed Univ Rio de Janeiro NICHD CRS |
Rio de Janeiro |
Brazil |
|
Hospital dos Servidores Rio de Janeiro |
Rio de Janeiro |
Brazil |
|
SOM Federal University Minas Gerais Brazil |
Minas Gerais |
Brazil |
|
Univ of Sao Paulo Brazil |
Sao Paulo |
Brazil |
|
Hosp. Geral De Nova Iguacu Brazil NICHD CRS |
Rio de Janeiro, Rio de Janeiro |
Brazil |
|
Hospital Nossa Senhora da Conceicao CRS |
Porto Alegre |
Brazil |
|
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS |
Port-au-Prince |
Haiti |
|
BJ Medical College CRS |
Pune, Maharashtra |
India |
|
Kenya Medical Research Institute - Walter Reed Project Clinical Research Center |
Kericho |
Kenya |
|
University of North Carolina Lilongwe CRS |
Lilongwe |
Malawi |
|
College of Medicine JHU CRS |
Blantyre |
Malawi |
|
Wits RHI Shandukani Research Centre CRS |
Johannesburg |
South Africa |
|
Soweto IMPAACT CRS |
Johannesburg |
South Africa |
|
Family Clinical Research Unit (FAM-CRU) CRS |
Cape Town |
South Africa |
|
CAPRISA Umlazi Clinical Research Site (UKZN) |
Umlazi, KwaZulu-Natal |
South Africa |
|
Kilimanjaro Christian Medical CRS |
Moshi |
Tanzania |
|
Siriraj Hospital Mahidol University CRS |
Bangkok |
Thailand |
|
Chiang Rai Regional Hospital CRS |
Muang |
Thailand |
|
Makerere University - Johns Hopkins University (MU-JHU CARE LTD) Research Collaboration CRS |
Kampala |
Uganda |
|
Baylor-Uganda CRS |
Kampala |
Uganda |
|
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 |
|
Univ of Washington Children's Hospital Seattle |
Seattle |
United States of America |
|
Emory University School of Medicine NICHD CRS |
Atlanta |
United States of America |
|
SUNY Stony Brook |
Stony Brook |
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 |
|
Rush University Cook County Hospital Chicago NICHD CRS |
Chicago |
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 |
|
St. Jude/UTHSC CRS |
Memphis |
United States of America |
|
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS |
San Juan |
United States of America |
|
St. Mary's CRS (Zimbabwe) |
Chitungwiza |
Zimbabwe |
|
Seke North CRS (Zimbabwe) |
Harare |
Zimbabwe |
|
Harare Family Care CRS |
Harare |
Zimbabwe |
Study contacts:
Study Co-Chair: Yvonne Bryson |
Study Co-Chair: Ellen Chadwick |
Study Vice-Chair: Mark Cotton |
DAIDS Medical Officer: Patrick Jean-Philippe |
NICHD Medical Officer: Rohan Hazra |
Clinical Trials Specialist: Anne Coletti |
Clinical Trials Specialist: Charlotte Perlowski |
CAB representative: Nagawa Jaliaah |
CAB representative: Marie Theunissen |
DAIDS Protocol Pharmacist: Lynette Purdue |
Data Manager: Christina Reding |
Data Manager: Bonnie Zimmer |
Field Representative: Chivon McMullen-Jackson |
Immunologist: Katherine Luzuriaga |
Investigator: Theodore Ruel |
Laboratory Data Manager (LDM): Rebecca LeBlanc |
Laboratory Specialist: Diane Costello |
Laboratory Technologist: Cheryl Jennings |
Pharmacologist: Edmund Capparelli |
Pharmacologist: Mark Mirochnick |
Statistician: Bryan Nelson |
Statistician: Camlin Tierney |
Virologist: Deborah Persaud |
Westat Representative: Scott Watson |