[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100353652":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":38,"overallOfficials":46,"centralContacts":50,"locations":58,"responsibleParty":74,"collaborators":77,"id":100,"slug":26,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":26,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":26,"enrollmentInfo":108,"targetDuration":26,"studyType":111,"phases":26,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Guangzhou 8th People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Virus suppression rate","ratio of HIV RNA \\\u003C 50 copies\u002FmL at 48 and 96 weeks of treatment","96 weeks",{"measure":14,"description":15,"timeFrame":12},"Adverse events","Rate of adverse events reported during the observational period",[17,20,23],{"measure":18,"description":19,"timeFrame":12},"The immunological ability (CD4+)","CD4 cell count (baseline to 48 weeks and 96 weeks)",{"measure":21,"description":22,"timeFrame":12},"Drug compliance","To explicit the number of people who have completed the treatment",{"measure":24,"description":25,"timeFrame":12},"The immunological ability (CD8+)","CD4 +\u002F CD8 + ratio (baseline to 48 weeks and 96 weeks)",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"CASE_ONLY","PROSPECTIVE","This study is an open-label, multicentered, single-arm and phase IV clinical trial. 300 HIV-infected patients who received simplified treatment regimen (50mg DTG+ 400mg 3TC, oral, qd) were selected to observe the treatment efficacy. At week 24, 36, 48 and 96, the rate of viral suppression and CD4 cell count were calculated against baseline. In addition, the safety and drug compliance were also monitored.","Patients who are prescribed to take the simplified therapy regimen (DTG+ 3TC) because they are unable to tolerate the side-effect of or are not fit for the first-line free regimen in China, for example renal failure or osteoporosis, according to clinical judgment, no matter of the HIV-RNA viral loads and CD4 cell counts.",[33],{"label":34,"type":26,"description":35,"interventionNames":36},"DTG+3TC","These cases were given simplified therapy regimen including DTG (50 mg, oral,qd) combined with 3TC (300 mg,oral,qd).",[37],"Drug: DTG+ 3TC",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","DTG+ 3TC","It is a simplified therapy regimen study of dolutegravir combined with lamivudine for HIV-1 infected patients in the real world of China.",[34],[45],"A simplified therapy regimen",[47],{"name":48,"affiliation":5,"role":49},"Weiping Cai, Bachelor","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":26,"email":55},"Linghua Li, PhD","CONTACT","020-83710825","llheliza@126.com",{"name":48,"role":53,"phone":54,"phoneExt":26,"email":57},"gz8hcwp@126.com",[59],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":67,"coordinates":68},"Point",[69,70],113.25,23.11667,{"lat":70,"lon":69},[73],{"name":52,"role":53,"phone":54,"phoneExt":26,"email":55},{"type":49,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Linghua LI","Vice Chief physician",[78,80,83,85,88,90,92,94,96,98],{"name":79,"class":6},"Shenzhen Third People's Hospital",{"name":81,"class":82},"Dongguan People's Hospital","OTHER_GOV",{"name":84,"class":6},"Fifth Affiliated Hospital, Sun Yat-Sen University",{"name":86,"class":87},"The Third People's Hospital of Guilin","UNKNOWN",{"name":89,"class":87},"Guangxi Longtan hospital",{"name":91,"class":6},"The Fourth People's Hospital of Nanning",{"name":93,"class":87},"The Third People's Hospital of Kunming",{"name":95,"class":6},"Yunnan AIDS Care Center",{"name":97,"class":6},"Meng Chao Hepatobiliary Hospital of Fujian Medical University",{"name":99,"class":6},"First Affiliated Hospital of Guangxi Medical University","100353652",false,"NCT03884673","Dolutegravir Plus Lamivudine Simplified Therapy","Real World Study: Dolutegravir Plus Lamivudine Simplified Therapy in Treatment Experienced HIV-1 Patients","Inclusion Criteria:\n\n1. Age (\\> 18 years), male and female;\n2. HIV-1 infected;\n3. Using a standard three-drug-based regimen for at least 24 weeks. Based on clinical decision making\\* decide if patients can be treated with the DTG+3TC simplified scheme for a variety of reasons, such as (but not limited to): patients cannot tolerate the conventional three-drug treatment scheme, renal insufficiency, osteoporosis, bone marrow suppression and for other reasons patients cannot use the conventional three-drug treatment scheme;\n4. Initial HIV-1 RNA viral load and CD4 cell count were unlimited.\n5. CD4 can be monitored at least three times in the first year (including baseline, 24 weeks of treatment and 48 weeks of treatment). After the first year, CD4 can be detected at least once every six months.\n6. State Informed Consent for Free Treatment has been signed;\n7. Good compliance and signing Informed Consent\n\n(\\* Reference criteria: Refer to APSIRE study, creatinine clearance rate (\\> 50 mL\u002Fmin), no DTG\u002F3TC allergy history, HBsAg negative, no chronic liver disease, no severe liver damage, no pregnancy during the study)\n\nExclusion Criteria:\n\n1. Has participated in other clinical trials of HIV vaccine or other drug trials in the past three months;\n2. Researchers decide if patients could\u002Fnot complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.).\n3. Has a clear history of DTG or 3TC allergy;\n4. HBsAg and\u002For HBV-DNA positive;\n5. Pregnancy during the study period.","ALL","18 Years",{"count":109,"type":110},300,"ESTIMATED","OBSERVATIONAL","Dolutegravir (DTG) is one type of integrase inhibitor, lamivudine (3TC) is one type of reverse transcriptase inhibitor, both of which are HIV medicine prevents HIV from self-multiplying, reduces the viral load. The data of the existing randomized controlled clinical studies show that the simplified two-drug DTG-based regimen is similar to the three-drug regimen in terms of efficacy, but there are no relevant data and reports on the efficacy and safety of DTG+3TC in HIV-infected patients in China so far. This project aims to explore the efficacy and safety of the DTG + 3TC regimen for HIV-infected patients in real clinical environment, to guide clinical application, and to provide a theoretical basis for the selection of simplified schemes for the formulation of guidelines.\n\nThis study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV.",[114],"HIV\u002FAIDS",[116,117,118,119],"DTG + 3TC Simplified Therapy","Simplified Therapy Regimen","Real World Study","HIV-1-infected patients","2022-09-13",{"date":122,"type":123},"2022-09-14","ACTUAL",{"date":125,"type":123},"2019-01-01",{"date":127,"type":110},"2030-12-31",{"name":5,"class":6},1]