P1092 (DAIDS ID 11689): Phase IV Evaluation of the Steady State Pharmacokinetics of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1-Infected Children

Study Status Study Restriction

Closed to Accrual

Non-US

What is P1092?

P1092 is a Phase IV, multi-center, pharmacokinetic study of zidovudine (ZDV), lamivudine (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished HIV-infected children (ages 6 to < 36 months).  The study is designed to assess the pharmacokinetic exposure, safety, and tolerability of ZDV, 3TC, and LPV/r in severely malnourished children compared to children with normal nutrition.

Study Documents:

      Please note - as of November 2016, the South African Department of Health has requested that all import permit applications be accompanied by either an MTA or a letter from the country of origin, indicating their knowledge about the export. Please contact Jennifer Norman (jennifer.norman@uct.ac.za) with any questions.

Study Trainings:

P1092 Startup Training - 15 June 2015

Sites where the study is implemented:

CRS ID Site Name City Country

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

30301

College of Medicine JHU CRS

Blantyre

Malawi

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Chair: Maxensia Owor

Study Vice-Chair: Philippa Musoke

DAIDS Medical Officer: Renee Browning

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Sarah Bradford

Clinical Trials Specialist: Anne Coletti

Data Manager: Bobbie Graham

Data Manager: Christina Reding

Drug Co. Representative: Wendy Snowden

Immunologist: Elizabeth (Betsy) McFarland

Investigator: Linda Barlow-Mosha

Investigator: Irene Lubega

Laboratory Data Manager (LDM): Kyle Lambert

Laboratory Data Manager (LDM): Amanda Zadzilka

Laboratory Specialist: Diane Costello

Laboratory Technologist: Nancy Tustin

Pharmacologist: Francesca Aweeka

Pharmacologist: Lubbe Wiesner

Protocol Pharmacist: Lynette Purdue

Statistician: Min Qin

Statistician: Lauren Ziemba

 

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.