P1106 (DAIDS ID 11882): Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants

Study Status Study Restriction

Enrolling

Non-US

What is P1106?

P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis, tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment containing lopinavir/ritonavir (LPV/r). The study is designed to describe the pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the drug(s) as part of clinical care.

Study Documents:

Study Training:

Sites where the study is implemented:

CRS ID Site Name City Country

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

31790

Desmond Tutu TB Centre - Stellenbosch University (SU) CRS

Cape Town

South Africa

Study contacts:

Study Co-Chair: Mark Cotton

Study Co-Chair: Mark Mirochnick

Study Vice-Chair: Adrie Bekker

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: JL Ariansen

Clinical Trials Specialist: Katie McCarthy

DAIDS Clinical Representative: Judi Miller

Data Manager: Bobbie Graham

Data Manager: Stephanie Popson

Field Representative: Nasreen Abrahams

Field Representative: Joan Coetzee

Investigator: Elaine Abrams

Investigator: Diana Clarke

Investigator: Helen McIlleron

Investigator: James McIntyre

Investigator: Helena Rabie

Investigator: Peter Smith

Laboratory Data Manager (LDM): Anthony Bloom

Laboratory Data Manager (LDM): Christopher Hensel

Laboratory Specialist: Carolyn Yanavich

Laboratory Technologist: Amy James Loftis

Pharmacologist: Edmund Capparelli

Statistician: Mae Cababasay

Statistician: Jiajia Wang

 

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.