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P1110 / Safety and PK of RAL in Neonates

A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1 Exposed Infants at High Risk

Study Status

Concluded

DAIDS Number

11891

IND Number

77,787

Clinical Trials Link

Study Chair

Study Vice-Chair

Clinical Research Manager

Data Manager

Laboratory Data Manager (LDM)

Laboratory Specialist

Laboratory Technologist

Pharmacologist

Protocol Pharmacist

Senior Statistician

Statistician

Virologist

Westat Representative

Manuscripts

Abstracts

Raltegravir pharmacokinetics and safety in HIV-1 exposed neonates: dose-finding study

Conference

CROI 2017

Study

P1110

Authors

DF Clarke, EP Acosta, A Chain, J Wang, M Cababasay, H Teppler, E Smith, R Hazra, M Mirochnick, IMPAACT P1110 Protocol Team

Raltegravir dosing in neonates (IMPAACT P1110) – Use of allometry and PK modeling to develop a daily dosing regimen for investigation during first weeks of life.

Conference

Population Approach Group in Europe (PAGE) Meeting

Study

P1110

Authors

Jos Lommerse, Diana F Clarke, Anne Chain, Han Witjes, Hedy Teppler, Edmund Capparelli, Edward P Acosta, Matthew Rizk, Larissa Wenning, Thomas Kerbusch, Stephen A Spector, Betsy Smith, Mark Mirochnick

Raltegravir PK in neonates– An adaptive trial design to define an appropriate regimen for neonates from birth to 6 weeks of age.

Conference

American Conference on Pharmacometrics (ACoP)

Study

P1110

Authors

Jos Lommerse, Diana Clarke, Anne Chain, Han Wities, Hedy Teppler, Edward Acosta, Edmund Capparelli, Matthew Rizk, Larissa Wenning, Thomas Kerbusch, Stephen Spector , Betsy Smith, Mark Mirochnick

Raltegravir (RAL) pharmacokinetics (PK) and safety in HIV-1 exposed neonates at high risk of infection (IMPAACT P1110)

Conference

IAS 2015

Study

P1110

Authors

Diana F. Clarke, Edward P. Acosta, Matthew Rizk, Yvonne Bryson, Stephen A. Spector, Lynne Mofenson, Mary Elizabeth Smith, Hedy Teppler, Carolee Welebob, Mae Cababasay, Bobbie Graham, Kat Richards, Mark Mirochnick , the P1110 Protocol Team

Raltegravir (RAL) Pharmacokinetics (PK) in HIV-1 Exposed Neonates at High Risk of Infection

Conference

IAS 2015

Study

P1110

Authors

Diana Clarke, Edward Acosta, Matthew Rizk, Yvonne Bryson, Stephen Spector, Lynne Mofenson, Mary Elizabeth Smith, Hedy Teppler, Carolee Welebob, Mae Cababasay, Bobbie Graham, Kat Richards, Mark Mirochnick, P1110 Protocol Team