IMPAACT 2026: Pharmacokinetic Properties of Antiretroviral, Anti-Tuberculosis, Contraceptive and Related Drugs During Pregnancy and Postpartum

Study Status Study Restriction

In Development

US & Non-US

What is IMPAACT 2026?

IMPAACT 2026 is a Phase IV, prospective, pharmacokinetic (PK) study of selected antiretroviral (ARV), anti-tuberculosis (TB), hormonal contraceptive, and related drugs during pregnancy and postpartum. The study is designed to evaluate the following: the PK of ARV medicines used in clinical care during pregnancy and postpartum; the PK of ARVs when used in combination with first-line TB medicines in clinical care during pregnancy and postpartum; the PK of second-line TB medicines when used in clinical care during pregnancy and postpartum; the kinetics of placental and breastmilk transfer of long-acting injectable ARVs after maternal dosing during pregnancy; the PK of selected ARVs in postpartum women before and after starting hormonal contraceptives; the concentrations of ethinyl estradiol, etonogestrel and other progestins in postpartum women using hormonal contraceptives and ARVs; and the kinetics of breastmilk transfer of ARV and TB drugs from mother to child during breastfeeding.

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Chair: Mark Mirochnick

Study Co-Chair: Brookie Best

Study Co-Chair: Alice Stek

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Nahida Chakhtoura

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Elizabeth Greene

Data Manager: Kayla Denson

Data Manager: Christina Reding

Investigator: Adrie Bekker

Investigator: Kristina Brooks

Investigator: Sandra Burchett

Investigator: Ahizechukwu Eke

Investigator: Anthony Garcia-Prats

Investigator: David Garry

Investigator: Amita Gupta

Investigator: Anneke Hesseling

Investigator: Regis Kreitchmann

Investigator: Kathleen Powis

Investigator: Marije Van Schalkwyk

Investigator: Lynn Yee

Laboratory Data Manager (LDM): Frederic Bone

Laboratory Data Manager (LDM): Kevin Knowles

Pharmacologist: Edmund Capparelli

Pharmacologist: Timothy Cressey

Pharmacologist: Jeremiah Momper

Statistician: David Shapiro

Statistician: Jiajia Wang

Virologist: Lisa Frenkel

 

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.