{"id":"antiretroviral-medications-isoniazid-prophylaxis","safety":{"commonSideEffects":[{"rate":null,"effect":"Peripheral neuropathy (isoniazid-related)"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Drug interactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Antiretroviral medications (typically including nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, or integrase inhibitors) block HIV replication at multiple steps of the viral lifecycle. Isoniazid is a prodrug that inhibits mycobacterial cell wall synthesis, providing prophylactic protection against tuberculosis (TB) in HIV-positive individuals at risk of TB co-infection or with latent TB infection.","oneSentence":"This combination uses antiretroviral drugs to suppress HIV replication while isoniazid prophylaxis prevents tuberculosis infection in co-infected patients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:02:06.311Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV infection with tuberculosis co-infection or latent TB infection requiring prophylaxis"},{"name":"Prevention of tuberculosis in HIV-positive patients"}]},"trialDetails":[{"nctId":"NCT05994742","phase":"PHASE3","title":"An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM","status":"ACTIVE_NOT_RECRUITING","sponsor":"Queen Mary University of London","startDate":"2024-07-15","conditions":"Severe Acute Malnutrition, HIV, Comorbidities and Coexisting Conditions","enrollment":674},{"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":"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":"NCT02383849","phase":"","title":"IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants","status":"COMPLETED","sponsor":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","startDate":"2015-08-04","conditions":"Low-Birth-Weight Infant, Tuberculosis, HIV","enrollment":124},{"nctId":"NCT03723525","phase":"PHASE4","title":"Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals","status":"COMPLETED","sponsor":"National Centre for AIDs and STD Control, Nepal","startDate":"2018-01-22","conditions":"HIV","enrollment":1073},{"nctId":"NCT00495651","phase":"PHASE3","title":"Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO)","status":"COMPLETED","sponsor":"French National Agency for Research on AIDS and Viral Hepatitis","startDate":"2008-03","conditions":"HIV Infections, Tuberculosis","enrollment":2073}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Antiretroviral medications+Isoniazid prophylaxis","genericName":"Antiretroviral medications+Isoniazid prophylaxis","companyName":"French National Agency for Research on AIDS and Viral Hepatitis","companyId":"french-national-agency-for-research-on-aids-and-viral-hepatitis","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination uses antiretroviral drugs to suppress HIV replication while isoniazid prophylaxis prevents tuberculosis infection in co-infected patients. Used for HIV infection with tuberculosis co-infection or latent TB infection requiring prophylaxis, Prevention of tuberculosis in HIV-positive patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}