P1093 (DAIDS ID 11773): Phase I/II, Multi-Center, Open-Label, Pharmacokinetic Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
| Study Status | Study Restriction |
|---|---|
Enrolling |
US & Non-US |
What is P1093?
P1093 is a Phase I/II, multi-center, open-label, non-comparative intensive pharmacokinetic and safety study of dolutegravir in combination regimens in HIV-1 infected infants, children and adolescents. The primary objectives of the study are to select a dolutegravir dose for chronic dosing; to determine the safety and tolerability of the dose, to evaluate the steady-state pharmacokinetics of dolutegravir in combination with other antiretrovirals and to determine the dose of dolutegravir that achieves the targeted C24h and AUC0-24 PK parameters in the population.
Study Documents:
PROTOCOL VERSION 5.0-
IMPAACT P1093 Protocol V5 with corrected CM#1, and CM #2 – 16 January 2019
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IMPAACT P1093 Summary of Changes from V4 to V5 – 12 July 2018
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IMPAACT P1093 Summary of Changes from V4 to V5 in Portuguese – 12 July 2018
» Study Trainings
Sites where the study is implemented:
| CRS ID | Site Name | City | Country |
|---|---|---|---|
Gaborone Prevention/Treatment Trials CRS |
Gaborone |
Botswana |
|
Molepolole Prevention/Treatment Trials CRS |
Molepolole |
Botswana |
|
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 |
|
Kenya Medical Research Institute - Walter Reed Project Clinical Research Center |
Kericho |
Kenya |
|
Wits RHI Shandukani Research Centre 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 |
|
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS |
Chiang Mai |
Thailand |
|
Makerere University - Johns Hopkins University (MU-JHU CARE LTD) Research Collaboration 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 |
|
San Juan City Hospital |
San Juan |
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 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 |
|
Harare Family Care CRS |
Harare |
Zimbabwe |
Study contacts:
Study Co-Chair: Theodore Ruel |
Study Co-Chair: Andrew Wiznia |
DAIDS Medical Officer: Ellen Townley |
NICHD Medical Officer: Rohan Hazra |
Clinical Trials Specialist: Kathleen George |
Clinical Trials Specialist: Nicole Montañez |
DAIDS Clinical Representative: Judi Miller |
Data Manager: Stephanie Popson |
Laboratory Data Manager (LDM): Katelyn Hergott |
Laboratory Specialist: Frances Whalen |
Laboratory Technologist: Patricia Anthony |
Pharmaceutical Company Representative: Annie Buchanan |
Pharmaceutical Company Representative: Rajendra Singh |
Pharmaceutical Company Representative: Cindy Vavro |
Pharmacologist: Edward Acosta |
Protocol Pharmacist: Thucuma Sise |
Statistician: Carmelita Alvero |
Statistician: Terence Fenton |
Virologist: Paul Palumbo |
Westat Representative: Kathryn Myers |