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IMPAACT 2001
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
Participants Off Study and Primary Analysis Completed
DAIDS Number
12026
IND Number
128,769
Clinical Trials Link
Primary Protocol Team Members
Summary
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.
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