{"id":"isoniazid-and-rifapentine","safety":{"commonSideEffects":[{"rate":"null","effect":"Hepatotoxicity"},{"rate":"null","effect":"Neuropathy"},{"rate":"null","effect":"Gastrointestinal disturbances"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Isoniazid is a prodrug that is activated by the enzyme catalase-peroxidase in M. tuberculosis. It then inhibits the enzyme enoyl-acyl carrier protein reductase (InhA), which is essential for the synthesis of mycolic acid. Rifapentine, on the other hand, is a rifamycin antibiotic that inhibits DNA-dependent RNA polymerase, which is necessary for the transcription of M. tuberculosis genes.","oneSentence":"Isoniazid and rifapentine work by inhibiting the synthesis of mycolic acid in Mycobacterium tuberculosis, ultimately leading to the death of the bacteria.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:48:54.030Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Pulmonary tuberculosis"},{"name":"Meningeal tuberculosis"}]},"trialDetails":[{"nctId":"NCT06568484","phase":"PHASE2, PHASE3","title":"Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB","status":"NOT_YET_RECRUITING","sponsor":"Johns Hopkins University","startDate":"2026-07","conditions":"Tuberculosis, Latent","enrollment":2530},{"nctId":"NCT06153069","phase":"PHASE4","title":"Asymptomatic TB With Innovative Modified Short-course Regimens","status":"RECRUITING","sponsor":"Huashan Hospital","startDate":"2025-11-21","conditions":"Tuberculosis","enrollment":426},{"nctId":"NCT07069582","phase":"PHASE1","title":"Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women","status":"NOT_YET_RECRUITING","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2026-04-01","conditions":"Tuberculosis Infection, Healthy Volunteer, Breastfeeding","enrollment":60},{"nctId":"NCT03089983","phase":"NA","title":"Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings","status":"COMPLETED","sponsor":"Yale University","startDate":"2017-08-21","conditions":"Opioid Dependence, Addiction, HIV/AIDS","enrollment":316},{"nctId":"NCT07124559","phase":"PHASE1, PHASE2","title":"A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","status":"NOT_YET_RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2026-05-15","conditions":"Tuberculosis","enrollment":144},{"nctId":"NCT05411744","phase":"PHASE4","title":"One-month Latent Tuberculosis Treatment for Renal Transplant Candidates","status":"ACTIVE_NOT_RECRUITING","sponsor":"Rutgers, The State University of New Jersey","startDate":"2022-07-01","conditions":"Latent Tuberculosis, End Stage Renal Disease, Renal Transplant Candidate for Right Kidney","enrollment":25},{"nctId":"NCT06214910","phase":"NA","title":"ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa","status":"COMPLETED","sponsor":"University of Washington","startDate":"2024-02-20","conditions":"Tuberculosis, HIV I Infection","enrollment":301},{"nctId":"NCT07086820","phase":"NA","title":"Window Prophylaxis for Pediatric Tuberculosis Prevention Trial","status":"RECRUITING","sponsor":"Pontificia Universidad Catolica de Chile","startDate":"2025-10-27","conditions":"Tuberculosis Infection, Household Contacts, Children","enrollment":647},{"nctId":"NCT06022146","phase":"PHASE3","title":"TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts","status":"RECRUITING","sponsor":"Huashan Hospital","startDate":"2023-09-01","conditions":"Tuberculosis, Latent Tuberculosis","enrollment":3520},{"nctId":"NCT05122767","phase":"PHASE1, PHASE2","title":"Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)","status":"ACTIVE_NOT_RECRUITING","sponsor":"The Aurum Institute NPC","startDate":"2023-05-24","conditions":"Tuberculosis, HIV","enrollment":92},{"nctId":"NCT05118490","phase":"PHASE4","title":"Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"The Aurum Institute NPC","startDate":"2023-07-19","conditions":"HIV Seropositivity, Tuberculosis, Household Contact","enrollment":1000},{"nctId":"NCT05122026","phase":"PHASE1, PHASE2","title":"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","status":"ACTIVE_NOT_RECRUITING","sponsor":"The Aurum Institute NPC","startDate":"2024-01-17","conditions":"HIV Seropositivity, Pregnancy, Tuberculosis Infection","enrollment":252},{"nctId":"NCT05630872","phase":"PHASE2","title":"Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2024-02-13","conditions":"HIV-associated Tuberculosis","enrollment":30},{"nctId":"NCT02563327","phase":"PHASE3","title":"Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2016-05-30","conditions":"Tuberculosis","enrollment":53},{"nctId":"NCT04311502","phase":"PHASE2","title":"Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2021-11-05","conditions":"HIV, Tuberculosis","enrollment":104},{"nctId":"NCT04703075","phase":"PHASE4","title":"Ultra Curto (Ultra Short) TB Prevention Therapy","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2022-03-24","conditions":"Tuberculosis","enrollment":531},{"nctId":"NCT03730181","phase":"PHASE1, PHASE2","title":"Tuberculosis Clinical Trials Consortium Study 35","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2019-10-12","conditions":"Latent Tuberculosis","enrollment":62},{"nctId":"NCT03934931","phase":"NA","title":"Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2020-07-13","conditions":"Tuberculosis, Latent Tuberculosis, HIV/AIDS","enrollment":1656},{"nctId":"NCT06917495","phase":"PHASE2","title":"Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis","status":"NOT_YET_RECRUITING","sponsor":"Shandong University","startDate":"2025-04-05","conditions":"Mild Spinal Tuberculosis","enrollment":300},{"nctId":"NCT06191692","phase":"PHASE3","title":"1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam","status":"NOT_YET_RECRUITING","sponsor":"Freundeskreis Für Internationale Tuberkulosehilfe e.V","startDate":"2025-08-01","conditions":"Tuberculosis Infection","enrollment":350},{"nctId":"NCT03785106","phase":"PHASE3","title":"Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals","status":"ACTIVE_NOT_RECRUITING","sponsor":"The HIV Netherlands Australia Thailand Research Collaboration","startDate":"2019-08-15","conditions":"HIV-infected Participants With Latent TB Infection in High TB Burden Country","enrollment":2500},{"nctId":"NCT01582711","phase":"PHASE3","title":"Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2012-09","conditions":"Latent Tuberculosis Infection","enrollment":1002},{"nctId":"NCT06874725","phase":"PHASE4","title":"Latent Tuberculosis in Type 2 Diabetes","status":"ACTIVE_NOT_RECRUITING","sponsor":"Taichung Veterans General Hospital","startDate":"2018-04-18","conditions":"Latent Tuberculosis Infection","enrollment":552},{"nctId":"NCT06281834","phase":"PHASE1","title":"Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention","status":"RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2024-11-15","conditions":"Pediatric HIV Infection, Latent Tuberculosis","enrollment":25},{"nctId":"NCT02410772","phase":"PHASE3","title":"TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2016-01-25","conditions":"Tuberculosis","enrollment":2516},{"nctId":"NCT03474029","phase":"PHASE2, PHASE3","title":"Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI","status":"RECRUITING","sponsor":"Centers for Disease Control and Prevention","startDate":"2019-08-01","conditions":"Latent Tuberculosis","enrollment":3400},{"nctId":"NCT04272242","phase":"PHASE2","title":"Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2021-02-27","conditions":"HIV Infection, LTBI","enrollment":37},{"nctId":"NCT00023452","phase":"PHASE3","title":"Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2001-06","conditions":"Tuberculosis","enrollment":8053},{"nctId":"NCT03510468","phase":"PHASE1","title":"Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)","status":"COMPLETED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2018-06-12","conditions":"Healthy Volunteers","enrollment":51},{"nctId":"NCT06511180","phase":"","title":"Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation","status":"NOT_YET_RECRUITING","sponsor":"The Aurum Institute NPC","startDate":"2024-08","conditions":"TB - Tuberculosis, Household Contact, HIV","enrollment":1200},{"nctId":"NCT04856644","phase":"PHASE3","title":"Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pulmonary TB","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kaohsiung Veterans General Hospital.","startDate":"2020-01-01","conditions":"Tuberculosis, Pulmonary","enrollment":333},{"nctId":"NCT05021731","phase":"PHASE4","title":"Short-course Rifamycin-based Regimens for Latent Tuberculosis in Patients With End-stage Kidney Disease","status":"NOT_YET_RECRUITING","sponsor":"Miguel Santín","startDate":"2024-04-20","conditions":"Latent Tuberculosis, Kidney Failure","enrollment":225},{"nctId":"NCT04094012","phase":"PHASE3","title":"Risk of SDRs Under 3HP and 1HP Regimen for LTBI","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2019-09-24","conditions":"Latent Tuberculosis Infection","enrollment":490},{"nctId":"NCT05330884","phase":"PHASE3","title":"BCG Revaccination in Children and Adolescents","status":"SUSPENDED","sponsor":"Tuberculosis Research Centre, India","startDate":"2024-07-15","conditions":"Tuberculosis Infection, Tuberculosis","enrollment":9200},{"nctId":"NCT05401071","phase":"PHASE2, PHASE3","title":"Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)","status":"RECRUITING","sponsor":"Huashan Hospital","startDate":"2023-01-13","conditions":"Tuberculosis, Pulmonary","enrollment":2442},{"nctId":"NCT03266991","phase":"PHASE4","title":"Treatment of Latent Tuberculosis in Socially Marginalised Citizens","status":"TERMINATED","sponsor":"Aarhus University Hospital","startDate":"2017-10-27","conditions":"Compliance, Patient","enrollment":22},{"nctId":"NCT03474198","phase":"PHASE2, PHASE3","title":"Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis","status":"COMPLETED","sponsor":"University College, London","startDate":"2018-03-21","conditions":"Tuberculosis, Pulmonary","enrollment":675},{"nctId":"NCT04600167","phase":"PHASE3","title":"Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus","status":"UNKNOWN","sponsor":"Dr. Nyanda Elias Ntinginya","startDate":"2022-06-17","conditions":"Diabetes Mellitus, Tuberculosis","enrollment":3000},{"nctId":"NCT03435146","phase":"PHASE1, PHASE2","title":"Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO)","status":"COMPLETED","sponsor":"The Aurum Institute NPC","startDate":"2018-01-18","conditions":"Respiratory Tract Infections, HIV Infections","enrollment":135},{"nctId":"NCT05454345","phase":"PHASE3","title":"Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment","status":"NOT_YET_RECRUITING","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2022-10-01","conditions":"Tuberculosis, Pulmonary","enrollment":620},{"nctId":"NCT05085171","phase":"PHASE3","title":"An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease","status":"RECRUITING","sponsor":"Makerere University","startDate":"2022-05-04","conditions":"The Study Will Focus on Assessing the Survival Benefit on an Enhanced Package of Care for Patients With Advanced HIV Disease","enrollment":2400},{"nctId":"NCT02771249","phase":"PHASE1","title":"Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers","status":"COMPLETED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2016-06-03","conditions":"HIV Infected Population With Latent Tuberculosis","enrollment":37},{"nctId":"NCT01404312","phase":"PHASE3","title":"Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2012-05-23","conditions":"Tuberculosis, HIV Infections","enrollment":3000},{"nctId":"NCT02651259","phase":"PHASE1, PHASE2","title":"Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2017-03-13","conditions":"Tuberculosis","enrollment":50},{"nctId":"NCT02099240","phase":"EARLY_PHASE1","title":"Patients Response to Early Switch To Oral:Osteomyelitis Study","status":"TERMINATED","sponsor":"Julio Ramirez","startDate":"2014-03-06","conditions":"Osteomyelitis","enrollment":11},{"nctId":"NCT02641106","phase":"NA","title":"VDOT for Monitoring Adherence to LTBI Treatment","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2016-03-08","conditions":"Tuberculosis, Latent Tuberculosis Infection","enrollment":129},{"nctId":"NCT04528277","phase":"PHASE3","title":"Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis","status":"UNKNOWN","sponsor":"Huashan Hospital","startDate":"2020-09-01","conditions":"Infertility, Female, Recurrent Implantation Failure, Genital Tuberculoses, Female","enrollment":1050},{"nctId":"NCT02430259","phase":"PHASE3","title":"Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention","status":"COMPLETED","sponsor":"Huashan Hospital","startDate":"2015-03","conditions":"Silicosis, Tuberculosis","enrollment":566},{"nctId":"NCT03886701","phase":"PHASE1","title":"Doravirine, Rifapentine and Isoniazid Interaction","status":"COMPLETED","sponsor":"Walter K. Kraft","startDate":"2019-04-22","conditions":"Latent Tuberculosis, Human Immunodeficiency Virus, Rifamycins Causing Adverse Effects in Therapeutic Use","enrollment":11},{"nctId":"NCT02980016","phase":"PHASE3","title":"Evaluation of the Effect of 3HP vs Periodic 3HP vs 6H in HIV-Positive Individuals","status":"COMPLETED","sponsor":"The Aurum Institute NPC","startDate":"2016-11","conditions":"Tuberculosis, HIV","enrollment":4027},{"nctId":"NCT03900858","phase":"NA","title":"Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)","status":"UNKNOWN","sponsor":"Huashan Hospital","startDate":"2018-12-01","conditions":"Silicosis Tuberculosis","enrollment":566},{"nctId":"NCT02735590","phase":"PHASE2, PHASE3","title":"The Correlate of Risk Targeted Intervention Study","status":"UNKNOWN","sponsor":"University of Cape Town","startDate":"2016-09-20","conditions":"Tuberculosis","enrollment":2927},{"nctId":"NCT00728507","phase":"PHASE2","title":"Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis","status":"TERMINATED","sponsor":"Johns Hopkins University","startDate":"2009-11","conditions":"Tuberculosis","enrollment":121},{"nctId":"NCT02208427","phase":"PHASE3","title":"Toward a Safe and Reachable Preventive Therapy for LTBI: a Multicenter Randomized Controlled Study in Taiwan","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2014-08","conditions":"Latent Tuberculosis Infection","enrollment":283},{"nctId":"NCT00164450","phase":"NA","title":"TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2005-09","conditions":"Tuberculosis","enrollment":230},{"nctId":"NCT00023387","phase":"NA","title":"TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2000-03","conditions":"Tuberculosis","enrollment":36},{"nctId":"NCT00023335","phase":"PHASE3","title":"TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"1995-04","conditions":"Pulmonary Tuberculosis","enrollment":1000}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":93,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["INH/RPT","1H3P3","PRIFTIN","RPT","P"],"phase":"phase_3","status":"active","brandName":"isoniazid and rifapentine","genericName":"isoniazid and rifapentine","companyName":"National Taiwan University Hospital","companyId":"national-taiwan-university-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Isoniazid and rifapentine work by inhibiting the synthesis of mycolic acid in Mycobacterium tuberculosis, ultimately leading to the death of the bacteria. Used for Pulmonary tuberculosis, Meningeal tuberculosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}