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

Study Location:

Topic:

Maternal-Child Health and HIVTuberculosis and HIV

Enrollment:

Closed

Trial Period:

Completed

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

Categories

Location
Topic

Clinical Trials

P2010: Phase III Study of the Virologic Efficacy and Safety...

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a...

Read More

A5300/P2003: PHOENIx Feasibility Study

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Read More

The Pharmacokinetics, Safety and Acceptability of New...

PK, safety and acceptability data and practical guidance on the optimal dosing of new more child-friendly formulations of...

Read More

P1077BF: Breastfeeding Version of the PROMISE Study...

1077BF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting...

Read More

A5253: Sensitivity and Specificity of Mycobacterium...

An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with...

Read More