NCT02651259View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 13, 2017

Primary Completion Date

April 10, 2019

Study Completion Date

April 10, 2019

Conditions
Tuberculosis
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.

Trial Locations (5)

10700

Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok

20200

Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS, Kericho

HT-6110

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince

Unknown

Malawi CRS, Lilongwe

Harare Family Care CRS, Harare

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02651259 - Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women | Biotech Hunter | Biotech Hunter