P2001 (DAIDS ID 12026): Evaluating 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
TB is a major cause of illness and death in women of reproductive age. Pregnant and postpartum women with latent TB are at higher risk of developing active TB. This study will evaluate the pharmacokinetics, tolerability, and safety of 12 once-weekly doses of RPT and INH in HIV-1-infected and HIV-1-uninfected pregnant and postpartum women with latent TB.
This study will enroll HIV-1-infected and HIV-1-uninfected pregnant women with latent TB and their infants into two cohorts based on gestation. Cohort 1 participants will be enrolled in their second trimester (greater than or equal to 14 to less than 28 weeks), and Cohort 2 participants will be enrolled in their third trimester (greater than or equal to 28 to less than or equal to 34 weeks). All participants will receive 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) during their study visits at weeks 1-12. Study researchers will perform an interim analysis during the study, and a dose adjustment may be recommended based on this analysis.
Study visits will occur at days 0-3, once a week for weeks 1-12, and once a month until 24 weeks after delivery. Visits will include physical examinations, obstetrical exams, and blood collection. Infants will be followed monthly until 24 weeks after birth.
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02651259 History of Changes
Other Study ID Numbers: IMPAACT 2001 12026
Study First Received: January 7, 2016
Last Updated: February 20, 2017