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

Study Status Study Restriction

Open to Accrual

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 (jennifer.norman@uct.ac.za) with any questions.

Study Trainings:

IMPAACT 2001 Startup Training – 14 June 2016

Sites where the study is implemented:

CRS ID Site Name City Country

30022

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

Port-au-Prince

Haiti

5121

Kenya Medical Research Institute - Walter Reed Project Clinical Research Center

Kericho

Kenya

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

31890

Harare Family Care CRS

Harare

Zimbabwe

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 Cokley

DAIDS Protocol Pharmacist: Oladapo Alli

Data Manager: Stephanie Popson

Drug Co. Representative: Brigitte Demers

Investigator: Adrie Bekker

Investigator: Richard Chaisson

Investigator: Cathy Cluver

Investigator: Amita Gupta

Investigator: Neil Martinson

Investigator: Vidya Mave

Investigator: Helen McIlleron

Laboratory Data Manager (LDM): Laura Hovind

Laboratory Data Manager (LDM): Rebecca LeBlanc

Laboratory Specialist: William Murtaugh

Laboratory Specialist: Carolyn Yanavich

Laboratory Technologist: Vandana Kulkarni

Pharmacologist: Rada Savic

Pharmacologist: Peter Smith

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.