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P1093 / PK, Safety, Tolerability and Antiviral Activity of Dolutegravir

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

DAIDS Number

11773

IND Number

110,847

Clinical Trials Link

Summary

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.

DAIDS Medical Officer

Clinical Research Manager

DAIDS Clinical Representative

Laboratory Data Manager (LDM)

Laboratory Specialist

Laboratory Technologist

Pharmaceutical Company Representative

Pharmacologist

Protocol Pharmacist

Virologist

Westat Representative

Abstracts

Genotypic and Phenotypic Dolutegravir Resistance in Pregnant Women and Children Living with HIV-1

Study

IMPAACT 2010, P1093

Authors

CL Boyce, RA Smith, R Nixon, MD Bishop, SM Styrchak, K Knowles, S Brummel, TD Ruel, A Wiznia, S Lockman, L Chinula, PK Drain, GS Gottlieb, LM Frenkel

Prevalence and dynamics of drug resistance during dolutegravir-containing treatment in a pediatric population living with HIV-1 (IMPAACT P1093)

Conference

IAS 2023

Study

P1093, P1093

Authors

Ceejay L. Boyce, Marley D. Bishop, Sheila M. Styrchak, Kevin Knowles, Cindy Vavro, Rohan Hazra, Ellen Townley, Robert Nixon, Robert A. Smith, Geoffrey S. Gottlieb, Theodore D. Ruel, Andrew A. Wiznia, Lisa M. Frenkel, IMPAACT P1093 Team

IMPAACT 1093: Dolutegravir in 6-12 Year Old HIV Infected Children: 48-Week Results

Conference

CROI 2016

Study

P1093

Authors

Andrew Wiznia, Carmelita Alvero, Terry Fenton, Kathleen George, Ellen Townley, Rohan Hazra, Barb Heckman, Annie Buchannan, Cindy Vavro, Rolando Viani on behalf of the P1093 study team

PK and 4-week outcomes of dolutegravir dispersible tablets in HIV-infected children

Conference

CROI 2019

Study

P1093

Authors

T Ruel, E Acosta, R Singh, C Alvero, K George, S Popson, M Bartlett, A Buchanan, C Brothers, L Koech, T Vhembo, R Hazra, E Townley, A Wiznia, P1093 team

Pharmacokinetics, Safety, and Efficacy of Dolutegravir (DTG; S/GSK1349572) in HIV-1 Infected Adolescents: Preliminary analysis from IMPAACT 1093

Conference

XIX International AIDS Conference

Study

P1093

Manuscripts