{"id":"vaginal-tfv-gel","safety":{"commonSideEffects":[{"rate":null,"effect":"Vaginal irritation or discomfort"},{"rate":null,"effect":"Genital erythema"},{"rate":null,"effect":"Vulvovaginal candidiasis"},{"rate":null,"effect":"Abnormal vaginal discharge"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tenofovir is a nucleotide reverse transcriptase inhibitor that, when formulated as a vaginal microbicide gel, creates a protective barrier against HIV infection at the site of potential viral exposure. The drug is absorbed locally and systemically to inhibit HIV replication if viral exposure occurs during sexual intercourse. This approach provides women with a user-controlled prevention option independent of partner cooperation.","oneSentence":"Tenofovir (TFV) gel applied vaginally blocks HIV reverse transcriptase to prevent sexual transmission of HIV.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:40:48.701Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV prevention in women via vaginal application (CAPRISA 004 trial demonstrated efficacy)"}]},"trialDetails":[{"nctId":"NCT01448616","phase":"PHASE4","title":"Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding","status":"COMPLETED","sponsor":"University of Washington","startDate":"2012-02","conditions":"Herpes Simplex Type II","enrollment":73},{"nctId":"NCT00594373","phase":"PHASE1","title":"Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"HIV Infections","enrollment":30},{"nctId":"NCT00705679","phase":"PHASE2","title":"Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2009-08","conditions":"HIV Infections","enrollment":5029},{"nctId":"NCT00592124","phase":"PHASE2","title":"Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2008-06","conditions":"HIV Infections","enrollment":168},{"nctId":"NCT01768962","phase":"PHASE1","title":"Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel","status":"COMPLETED","sponsor":"CONRAD","startDate":"2014-04","conditions":"HIV Prevention","enrollment":14},{"nctId":"NCT01813162","phase":"PHASE1","title":"In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products","status":"COMPLETED","sponsor":"CONRAD","startDate":"2013-12","conditions":"HIV Prevention","enrollment":101},{"nctId":"NCT02245945","phase":"PHASE1","title":"Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females","status":"WITHDRAWN","sponsor":"CONRAD","startDate":"","conditions":"HIV Prevention","enrollment":""},{"nctId":"NCT01810315","phase":"PHASE1","title":"Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity","status":"COMPLETED","sponsor":"CONRAD","startDate":"2013-09","conditions":"HIV Prevention","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Tenofovir 1% Vaginal Gel"],"phase":"marketed","status":"active","brandName":"Vaginal TFV Gel","genericName":"Vaginal TFV Gel","companyName":"University of Washington","companyId":"university-of-washington","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tenofovir (TFV) gel applied vaginally blocks HIV reverse transcriptase to prevent sexual transmission of HIV. Used for HIV prevention in women via vaginal application (CAPRISA 004 trial demonstrated efficacy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}