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Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women

NCT02651259 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-11-04

Study results available
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Summary

The purpose of this study was to evaluate the pharmacokinetics (PK), tolerability, and safety of once-weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and HIV-1-uninfected pregnant and postpartum women with latent tuberculosis (TB).

Conditions

Interventions

DRUG

Rifapentine (RPT)

900 mg of RPT

DRUG

Isoniazid (INH)

900 mg of INH

DIETARY_SUPPLEMENT

Pyridoxine (vitamin B6)

25 mg to 100 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jyoti S. Mathad, MD, MSc · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2019-04-10
Completion
2019-04-10
FDA Drug
Yes

Countries

  • Haiti
  • Kenya
  • Malawi
  • Thailand
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02651259 on ClinicalTrials.gov