NCT01936831View on ClinicalTrials.gov

High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)

PHASE2CompletedINTERVENTIONAL
Enrollment

282

Participants

Timeline

Start Date

August 13, 2014

Primary Completion Date

September 22, 2021

Study Completion Date

October 6, 2021

Conditions
Tuberculosis
Interventions
DRUG

Isoniazid

INH was available in 100 mg tablets. INH was administered orally daily in the morning on an empty stomach. Doses of INH were given according to the weight bands and by cohort.

DIETARY_SUPPLEMENT

Vitamin B6

Vitamin B6 was administered at \>= 25 mg daily and was obtained locally for use by study participants.

Trial Locations (2)

7531

TASK Applied Science CRS (31718), Bellville

Unknown

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (31730), Port-au-Prince

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

NCT01936831 - High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB) | Biotech Hunter | Biotech Hunter