IMPAACT 2001 (DAIDS ID 12026): A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection

Study Status Study Restriction

Participants Off Study and Primary Analysis Completed

US & Non-US

What is IMPAACT 2001?

IMPAACT 2001 is a Phase I/II, prospective, open-label, multi-center study of HIV-1-infected and HIV-1-uninfected pregnant and postpartum women with latent tuberculosis (TB) infection. The study is designed to describe the pharmacokinetics and safety of 12 once-weekly doses of rifapentine (RPT) and isoniazid (INH) in pregnant and postpartum women with latent TB and inform the practice on usage of this regimen in the second and third trimesters of pregnancy.

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 ( with any questions.

Study Trainings:

Press and Presentations


Sites where the study is implemented:

CRS ID Site Name City Country


Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS




Kenya Medical Research Institute - Walter Reed Project Clinical Research Center




University of North Carolina Lilongwe CRS




Siriraj Hospital Mahidol University CRS




Harare Family Care CRS



Study contacts:

Study Chair: Jyoti Mathad

Study Vice-Chair: Kelly Dooley

Study Vice-Chair: Sandesh Patil

DAIDS Medical Officer: Ellen Townley

NICHD Medical Officer: Nahida Chakhtoura

Clinical Trials Specialist: Sarah Bradford

Clinical Trials Specialist: Jennifer Libous

CAB representative: Steven Mphonda

Community Program Manager: Cheryl Blanchette

DAIDS Protocol Pharmacist: Oladapo Alli

Data Manager: Bobbie Graham

Drug Co. Representative: Brigitte Demers

Drug Co. Representative: Andrew Hockey

Investigator: Richard Chaisson

Investigator: Amita Gupta

Laboratory Data Manager (LDM): Lauren Harriff

Laboratory Specialist: William Murtaugh

Laboratory Technologist: Vandana Kulkarni

Pharmacologist: Rada Savic

Statistician: Paula Britto

Statistician: Grace Montepiedra

Westat Representative: Kathryn Myers


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.