[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628869":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Ministry of Health, Saudi Arabia","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Optimised PYZ-HCQ Arm","EXPERIMENTAL","Participants receive AI-optimised combination of Pyrazinamide (PYZ) and Hydroxychloroquine (HCQ) for drug-sensitive pulmonary tuberculosis. AI algorithms determine optimal dosing and duration based on patient pharmacokinetic and pharmacogenomic parameters over a 4-month intensive phase followed by 2-month continuation phase.",[13],"Drug: Pyrazinamide and Hydroxychloroquine (AI-Optimised)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard RIPE Regimen Arm","ACTIVE_COMPARATOR","Participants receive standard WHO-recommended RIPE regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol) for drug-sensitive pulmonary tuberculosis. Standard 2-month intensive phase followed by 4-month continuation phase with Rifampicin and Isoniazid.",[19],"Drug: Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Pyrazinamide and Hydroxychloroquine (AI-Optimised)","AI-optimised combination drug regimen consisting of Pyrazinamide (PYZ) and Hydroxychloroquine (HCQ) for treating drug-sensitive pulmonary tuberculosis. Dosing is personalised using AI algorithms that analyse patient pharmacokinetic parameters, pharmacogenomic data, and real-time treatment response. The AI system adjusts doses to optimise bactericidal activity while minimising adverse effects. PYZ dose: 15-30 mg\u002Fkg\u002Fday; HCQ dose: 200-400 mg\u002Fday, duration adjusted per AI protocol over 6 months.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)","Standard WHO first-line anti-tuberculosis treatment regimen: 2 months of Rifampicin (R) 10 mg\u002Fkg\u002Fday, Isoniazid (I) 5 mg\u002Fkg\u002Fday, Pyrazinamide (Z) 25 mg\u002Fkg\u002Fday, and Ethambutol (E) 15 mg\u002Fkg\u002Fday (intensive phase), followed by 4 months of Rifampicin and Isoniazid (continuation phase). Total treatment duration: 6 months.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"amr K.K. Ahmed, MD, MSc","CONTACT","00966597310032","drmedahmed@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Riyadh First Health Cluster, Ministry of Health","Riyadh","Riyadh Region","11176","Saudi Arabia","SA",{"type":46,"coordinates":47},"Point",[48,49],46.72185,24.68773,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Amr Ahmed, MD, PhD","+966112010000","amr.ahmed@moh.gov.sa",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Amr kamel khalil Ahmed","Public Health Specialist, Principal Investigator","100628869","phase-2-aiph-tb-ai-optimised-pyrazinamide-hydroxychloroquine-vs-standard-ripe-for-drug-sensitive-pulmonary-tuberculosis---a-phase-ii-rct-100628869",false,"NCT07467252","AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT","A Phase II, Open-Label, Randomised, Parallel-Group, Active-Controlled Trial Evaluating the Efficacy, Safety, and Tolerability of AI-Optimised Pyrazinamide 1,500 mg \u002F Hydroxychloroquine 200 mg Twice Daily (AIPH-TB Protocol) Versus Standard Four-Drug RIPE Regimen in Adults With Newly Diagnosed Drug-Sensitive Pulmonary Tuberculosis","AIPH-TB-RCT-P2","Inclusion Criteria:\n\n* Confirmed diagnosis of drug-sensitive pulmonary tuberculosis (bacteriologically confirmed by positive sputum smear microscopy or GeneXpert MTB\u002FRIF)\n* Age 18 to 65 years\n* Naive to anti-tuberculosis treatment (no previous TB treatment or less than 1 month of TB treatment in the past)\n* Willing to provide written informed consent\n* Able to comply with study visits and procedures\n* HIV-negative or HIV-positive with CD4 count ≥200 cells\u002Fmm³ on stable antiretroviral therapy\n\nExclusion Criteria:\n\n* Drug-resistant tuberculosis (confirmed resistance to Rifampicin or Isoniazid)\n* Severe hepatic impairment (Child-Pugh Class C) or ALT\u002FAST \\>3 times upper limit of normal\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²)\n* Known hypersensitivity to Pyrazinamide, Hydroxychloroquine, or any RIPE drugs\n* Pregnancy or breastfeeding\n* Retinal disease or known contraindications to Hydroxychloroquine\n* Concomitant use of medications with significant interactions with study drugs\n* Extrapulmonary tuberculosis as the primary site\n* Currently enrolled in another clinical trial","ALL","18 Years","65 Years",{"count":72,"type":73},200,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of patients. Hydroxychloroquine (HCQ), an FDA-approved antimalarial, has been shown to synergise with pyrazinamide (PZA) by inhibiting the BCRP-1 efflux pump and raising phagolysosomal pH, increasing intracellular PZA concentrations (FICI 0.38 in vitro). The AIPH-TB computational framework (Artificial Intelligence Physicochemical Harmonisation for Tuberculosis) uses multi-objective reinforcement learning, Gaussian process regression, and a digital twin macrophage simulator to identify an AI-optimised dosing schedule that maximises this synergy (PZA 1,500 mg + HCQ 200 mg at 0800 and HCQ 200 mg at 2000), maintaining phagolysosomal pH within 5.2-5.8 for 18 of 24 hours. The computational model predicts FICI 0.28 (strongly synergistic), 9.4-fold increase in intracellular PZA concentration, 99.5% cure rate, and \\\u003C1.5% hepatotoxicity. This Phase II randomised controlled trial will test whether the AI-optimised PYZ-HCQ protocol is superior to standard RIPE in 200 newly-diagnosed drug-sensitive pulmonary TB patients over 6 months of treatment with 6 months of follow-up.",[79],"Pulmonary Tuberculosis",[81,82,83,84,85,86],"Tuberculosis","Pyrazinamide","Hydroxychloroquine","Artificial Intelligence","Drug-Sensitive TB","AIPH-TB","NOT_YET_RECRUITING","2026-03-09",{"date":90,"type":91},"2026-03-12","ACTUAL",{"date":93,"type":73},"2026-09",{"date":95,"type":73},"2028-06",{"name":5,"class":6},1]