20 completed, 2 not yet recruiting, 2 recruiting, 2 unknown. 28 Phase 1, 8 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 28 | Completed 20, Not yet recruiting 2, Recruiting 2, Unknown 2, Active not recruiting 1, Terminated 1 |
| Phase 2 | 8 | Completed 6, Active not recruiting 1, Recruiting 1 |
Follow Isoniazid: new trials by email Literature Review of Isoniazid trials Research Report on Isoniazid
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV Rifapentine, Isoniazid, Dolutegravir - Tuberculosis | Phase 1 / Phase 2 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 144 | 2026-09-28 | 2026-10-19 |
| Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women Standard dose rifampicin, High dose rifampicin, Standard dose isoniazid - Tuberculosis Infection, Healthy Volunteer | Phase 1 | Not yet recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | 60 | 2026-04-01 | 2026-02-10 |
| A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With Tuberculosis Isoniazid - Tuberculosis | Phase 1 | Recruiting | University Medical Center Groningen | 8 | 2025-12-01 | 2026-07-16 |
| Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi Silymarin 420 mg, N Acetyl Cysteine, Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z) - Drug Induced Liver Injury, Tuberculosis (TB) | Phase 1 | Not yet recruiting | Liaquat National Hospital & Medical College | 410 | 2025-07-01 | 2025-07-10 |
| Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV Rifapentine, Isoniazid - HIV Seropositivity, Pregnancy | Phase 1 / Phase 2 | Active not recruiting | The Aurum Institute NPC | 252 | 2024-01-17 | 2025-12-12 |
| Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention Low-dose isoniazid, Standard dose of isoniazid, High-dose isoniazid - Tuberculosis Infection, Isoniazid Adverse Reaction | Phase 1 | Completed | Stanford University | 78 | 2023-03-23 | 2026-06-15 |
| Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines BCG Vaccine USP, Isoniazid, Rifampin - Tuberculosis | Phase 1 | Completed | Fred Hutchinson Cancer Center | 20 | 2022-12-06 | 2025-12-16 |
| Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy Nivaquine ® (Chloroquine) - Tuberculosis Infection | Phase 1 | Unknown | University of Zurich | 16 | 2022-01-04 | 2024-07-01 |
| BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) BTZ-043, Rifafour e-275®, Probe Drug Cocktail - Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis | Phase 1 / Phase 2 | Completed | Michael Hoelscher | 78 | 2019-11-15 | 2026-08-31 |
| Tuberculosis Clinical Trials Consortium Study 35 Rifapentine, Isoniazid - Latent Tuberculosis | Phase 1 / Phase 2 | Completed | Centers for Disease Control and Prevention | 69 | 2019-11-12 | 2026-07-24 |
| Doravirine, Rifapentine and Isoniazid Interaction Doravirine (DOR), Rifapentine (RPT), Isoniazid (INH) - Latent Tuberculosis, Human Immunodeficiency Virus | Phase 1 | Completed | Walter K. Kraft | 11 | 2019-04-22 | 2020-03-27 |
| Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA) Tenofovir alafenamide, Rifapentine, Isoniazid (INH) - Healthy Volunteers | Phase 1 | Completed | National Institutes of Health Clinical Center (CC) | 51 | 2018-06-12 | 2024-08-13 |
| Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women Rifapentine (RPT), Isoniazid (INH), Pyridoxine (vitamin B6) - Tuberculosis | Phase 1 / Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 50 | 2017-03-13 | 2021-11-04 |
| Optimizing Treatment to Improve TBM Outcomes in Children High-dose: RIF, INH, PZA, EMB, High dose: RIF, INH, PZA, LEVO, Standard of care: RIF, INH, PZA, EMB - Tuberculosis, Meningeal | Phase 1 / Phase 2 | Completed | Johns Hopkins University | 38 | 2017-02-22 | 2021-10-28 |
| Pharmacokinetics of Efavirenz in the Presence of Rifampicin and Isoniazid Efavirenz, tenofovir /emtricitabine, tenofovir/lamivudine - HIV | Phase 1 | Unknown | St Stephens Aids Trust | 35 | 2016-11-21 | 2017-06-21 |
| The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB) Rimactane, Rifafour e-275, Rimactazid 150/75 - Tuberculosis | Phase 1 | Completed | University of Cape Town | 21 | 2016-11-01 | 2017-05-10 |
| Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers rifapentene (RPT), darunavir/cobicistat (DRV/c), Isoniazid (INH) - HIV Infected Population With Latent Tuberculosis | Phase 1 | Completed | National Institutes of Health Clinical Center (CC) | 37 | 2016-06-03 | 2022-04-18 |
| Brief Bactericidal Activity of Anti-Tuberculosis Drugs High dose isoniazid - Tuberculosis, Drug-resistant Tuberculosis | Phase 1 | Completed | Centers for Disease Control and Prevention | 18 | 2015-11-01 | 2020-10-19 |
| PK Study of Anti-TB Drugs Isoniazid (H), Rifampicin (R), Pyrazinamide (Z) - Tuberculosis | Phase 1 | Completed | University of Oxford | 61 | 2015-07-07 | 2018-10-03 |
| Phase I Study of Intralesional Bacillus Calmette-Guerin (BCG) Followed by Ipilimumab in Advanced Metastatic Melanoma Bacillus Calmette-Guérin (BCG) vaccine, Ipilimumab, Isoniazid - Metastatic Melanoma | Phase 1 | Terminated | Ludwig Institute for Cancer Research | 5 | 2014-03-01 | 2022-10-12 |
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Tuberculosis (16) · Latent Tuberculosis (8) · Acquired Immunodeficiency Syndrome (3) · AIDS-Related Opportunistic Infections (2) · HIV Infections (2) · Tuberculosis, Pulmonary (2) · Breast Feeding (1) · Chemical and Drug Induced Liver Injury (1) · Diabetes Mellitus, Type 2 (1) · Gram-Positive Bacterial Infections (1) · HIV Seropositivity (1) · Melanoma (1) · Respiratory Aspiration (1) · Tuberculosis, Meningeal (1) · Tuberculosis, Multidrug-Resistant (1)
National Institute of Allergy and Infectious Diseases (NIAID) (7) · Centers for Disease Control and Prevention (2) · National Institutes of Health Clinical Center (CC) (2) · Dance Biopharm Inc. (1) · Fred Hutchinson Cancer Center (1) · Johns Hopkins University (1) · Liaquat National Hospital & Medical College (1) · Ludwig Institute for Cancer Research (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · Michael Hoelscher (1) · Oswaldo Cruz Foundation (1) · Pfizer (1) · St Stephens Aids Trust (1) · Stanford University (1) · The Aurum Institute NPC (1)
United States (7) · South Africa (5) · Brazil (3) · Thailand (3) · Haiti (2) · India (2) · Kenya (2) · Malawi (2) · Uganda (2) · Zimbabwe (2) · Australia (1) · Botswana (1) · Indonesia (1) · Netherlands (1) · Philippines (1)
Joseph A Kovacs, M.D. (2) · Andreas Diacon, Prof (1) · Anneke Hesseling, MD (1) · Ariba Sultan (1) · Avy Violari, MD (1) · Clifton E Barry, Ph.D. (1) · Cohn J (1) · Constance Benson (1) · Diane Havlir (1) · Dick Menzies, MD (1) · Dr Vaneshree Govender (1) · Eduardo W Barroso, Dr (1) · Egorin M (1) · Hafner R (1) · Helen M McIlleron, PhD (1)
PMID 16776446, PMID 18070980, PMID 18787216, PMID 19564361, PMID 19923475, PMID 24135768, PMID 24814553, PMID 26400476, PMID 27412415, PMID 29145483, PMID 29415190, PMID 29552014, PMID 29584861, PMID 30084943, PMID 30939136, PMID 31611259, PMID 34323955, PMID 35291004, PMID 39793592, PMID 41504451, PMID 42156227, PMID 42568101
R01HD074944 (1), R21AI172182 (1)