Isoniazid

Generic Name: Isoniazid

Brand Names: Isonarif, Isotamine, Isotamine B, Rifamate, Rifater

Drug Type: Small Molecule

Chemical Formula: C_₆H_₇N_₃O

CAS Number: 54-85-3

Unique Ingredient Identifier: V83O1VOZ8L

Background: Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis.

Indication: Isoniazid is used for the treatment of all forms of tuberculosis in which organisms are susceptible. It is also used in combination with rifampin and pyrazinamide.

Associated Conditions: Active Tuberculosis, Mycobacterium kansasii infection, Late phase Tuberculosis

Associated Therapies: -

Clinical Trials

Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

Phase 3

Completed

Conditions: Human Immunodeficiency Virus

Interventions: Dietary Supplement: Ready to Use Supplementary Food
Drug: Fluconazole
Drug: Raltegravir
Drug: Azithromycin
Drug: Albendazole
Drug: Isoniazid

First Posted Date: 2013-04-05

Last Posted Date: 2016-04-20

Lead Sponsor: Anna Griffiths, MRC

Target Recruit Count: 1805

Registration Number: NCT01825031

Locations: 🇺🇬
Joint Clinical Research Centre, Mbale, Mbale, Uganda
🇰🇪
Moi University Clinical Research Centre, Eldoret, Kenya
🇰🇪
KEMRI Wellcome Trust Research Programme, Kilifi, Kenya

and more 5 locations

Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design

Phase 2

Completed

Conditions: Tuberculosis, Pulmonary

Interventions: Drug: SQ109
Drug: Rifampicin
Drug: Moxifloxacin
Drug: isoniazid
Drug: pyrazinamide
Drug: ethambutol
Dietary Supplement: pyridoxine

First Posted Date: 2013-02-07

Last Posted Date: 2017-09-20

Lead Sponsor: Michael Hoelscher

Target Recruit Count: 365

Registration Number: NCT01785186

Locations: 🇿🇦
The Aurum Institute for Health Research, Johannesburg, South Africa
🇿🇦
University of Cape Town, Centre for Tuberculosis Research Innovation, Cape Town, South Africa
🇹🇿
NIMR - Mbeya Medical Research Programme, Mbeya, Tanzania

and more 4 locations

"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients".

Phase 3

Terminated

Conditions: Latent Tuberculosis Infection
Infection in Solid Organ Transplant Recipients

Interventions: Drug: Isoniazid
Drug: Levofloxacin

First Posted Date: 2013-01-04

Last Posted Date: 2014-08-06

Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Target Recruit Count: 68

Registration Number: NCT01761201

Locations: 🇪🇸
Complejo Hospitalario de Albacete, Albacete, Spain
🇪🇸
Hospital Infanta Cristina,, Badajoz, Spain
🇪🇸
Hospital universitario Virgen de las Nieves, Granada, Spain

and more 15 locations

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

Phase 2

Terminated

Conditions: HIV Infection
Tuberculosis

Interventions: Drug: Standard-dose Lopinavir/Ritonavir
Drug: Double-dose Lopinavir/Ritonavir
Drug: Raltegravir
Drug: Isoniazid
Drug: Pyridoxine
Drug: Pyrazinamide
Drug: Ethambutol
Drug: Rifampin
Drug: Rifabutin

First Posted Date: 2012-05-18

Last Posted Date: 2018-02-13

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 71

Registration Number: NCT01601626

Locations: 🇵🇪
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301), Lima, Peru
🇧🇷
Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro, Brazil
🇭🇹
Les Centres GHESKIO CRS (30022), Port-au-Prince, Haiti

and more 6 locations

Essentiality of INH in TB Therapy

Phase 2

Completed

Conditions: Tuberculosis

Interventions: Drug: Rifampicin
Drug: Isoniazid
Drug: Pyrazinamide
Drug: Ethambutol
Drug: Moxifloxacin

First Posted Date: 2012-05-02

Last Posted Date: 2018-04-06

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 69

Registration Number: NCT01589497

Locations: 🇿🇦
TASK Applied Science CRS (31718), Bellville, South Africa
🇿🇦
University of Cape Town Lung Institute (UCTLI) CRS (31792), Cape Town, Western Cape, South Africa

Effect of Isoniazid on Protoporphyrin Levels in Erythropoietic Protoporphyria

Not Applicable

Terminated

Conditions: X Linked Erythropoietic Protoporphyria
Erythropoietic Protoporphyria (EPP)

Interventions: Drug: Isoniazid

First Posted Date: 2012-03-12

Last Posted Date: 2017-01-16

Lead Sponsor: University of Utah

Target Recruit Count: 11

Registration Number: NCT01550705

Locations: 🇺🇸
University of Utah School of Medicine, Salt Lake City, Utah, United States

REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment

Phase 4

Completed

Conditions: HIV Infection

Interventions: Drug: Atripla (r)
Drug: Efavirenz
Drug: Truvada
Drug: Rifampin/isoniazid/pyrazinamide/ethambutol FDC
Drug: Isoniazid
Drug: Rifampin/isoniazid FDC

First Posted Date: 2011-06-27

Last Posted Date: 2024-10-14

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 851

Registration Number: NCT01380080

Locations: 🇮🇳
BJ Medical College CRS, Pune, Maharashtra, India
🇮🇳
YRG CARE Medical Ctr., VHS Chennai CRS, Rajiv Gandhi Salai Taramani, Chennai, India
🇭🇹
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port Au Prince, Haiti

and more 15 locations

Study of Pre-clearance of Latent Tuberculosis Infection And BCG Revaccination

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Biological: BCG strain Danish
Drug: Isoniazid

First Posted Date: 2010-05-07

Last Posted Date: 2017-01-09

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 82

Registration Number: NCT01119521

Locations: 🇿🇦
University of Cape Town - Institute of Infectious Disease and Molecular Medicine, Cape Town, Western Cape, South Africa

Randomized Clinical Trial Comparing 4RIF vs. 9INH for LTBI Treatment-effectiveness

Phase 3

Completed

Conditions: Latent Tuberculosis Infection

Interventions: Drug: Isoniazid
Drug: Rifampin

First Posted Date: 2009-07-02

Last Posted Date: 2017-12-19

Lead Sponsor: McGill University

Target Recruit Count: 6031

Registration Number: NCT00931736

Locations: 🇦🇺
Woolcock Institute of Medical Research, Sydney, New South Wales, Australia
🇬🇭
Research and Development Unit, Komfo Anokye Teaching Hospital, Kumasi, Ghana
🇬🇳
Service de Phtisiologie, Hopital National Ignace Deen, Conakry, Guinea

and more 9 locations

Measurement of Anti-TB Drugs in Lung Tissue From Patients Having Surgery to Treat Tuberculosis

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Drug: Rifampicin
Drug: Isoniazid
Drug: Pyrazinamide
Drug: Kanamycin
Drug: Moxifloxacin

First Posted Date: 2009-01-01

Last Posted Date: 2019-12-09

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 19

Registration Number: NCT00816426

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of
🇰🇷
Pusan National Unversity Hospital (PNUH), Busan, Korea, Republic of
🇰🇷
National Medical Center, Seoul, Korea, Republic of

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