[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054987":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":14,"responsibleParty":7,"collaborators":7,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":7,"eligibilityCriteria":109,"healthyVolunteers":106,"sex":110,"minAge":111,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":120,"whyStopped":7,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":125,"locationsCount":127},{"fullName":5,"class":6},"NIH AIDS Clinical Trials Information Service","INDUSTRY",null,[9,12],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Butyldeoxynojirimycin",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"Zidovudine",[15,28,37,47,56,66,76,86,95],{"facility":16,"status":7,"city":17,"state":18,"zip":19,"country":20,"countryCode":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":7},"Dr Marcus Conant","San Francisco","California","94115","United States","US",{"type":23,"coordinates":24},"Point",[25,26],-122.41942,37.77493,{"lat":26,"lon":25},{"facility":29,"status":7,"city":30,"state":18,"zip":31,"country":20,"countryCode":21,"cosmosGeoPoint":32,"geoPoint":36,"contacts":7},"Shared Med Research Foundation","Tarzana","91356",{"type":23,"coordinates":33},[34,35],-118.55397,34.17334,{"lat":35,"lon":34},{"facility":38,"status":7,"city":39,"state":40,"zip":41,"country":20,"countryCode":21,"cosmosGeoPoint":42,"geoPoint":46,"contacts":7},"Stratogen of South Florida","Miami Beach","Florida","33140",{"type":23,"coordinates":43},[44,45],-80.13005,25.79065,{"lat":45,"lon":44},{"facility":48,"status":7,"city":49,"state":40,"zip":50,"country":20,"countryCode":21,"cosmosGeoPoint":51,"geoPoint":55,"contacts":7},"Saint Joseph's Hosp \u002F Infectious Disease Rsch Institute","Tampa","33614",{"type":23,"coordinates":52},[53,54],-82.45843,27.94752,{"lat":54,"lon":53},{"facility":57,"status":7,"city":58,"state":59,"zip":60,"country":20,"countryCode":21,"cosmosGeoPoint":61,"geoPoint":65,"contacts":7},"West Paces Clinical Research Incoporated","Atlanta","Georgia","30327",{"type":23,"coordinates":62},[63,64],-84.38798,33.749,{"lat":64,"lon":63},{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":20,"countryCode":21,"cosmosGeoPoint":71,"geoPoint":75,"contacts":7},"Dr Samuel W Golden","Pittsburgh","Pennsylvania","15218",{"type":23,"coordinates":72},[73,74],-79.99589,40.44062,{"lat":74,"lon":73},{"facility":77,"status":7,"city":78,"state":79,"zip":80,"country":20,"countryCode":21,"cosmosGeoPoint":81,"geoPoint":85,"contacts":7},"Dallas Veterans Administration Med Ctr","Dallas","Texas","75216",{"type":23,"coordinates":82},[83,84],-96.80667,32.78306,{"lat":84,"lon":83},{"facility":87,"status":7,"city":88,"state":79,"zip":89,"country":20,"countryCode":21,"cosmosGeoPoint":90,"geoPoint":94,"contacts":7},"Dr Daniel Barbero","Fort Worth","76104",{"type":23,"coordinates":91},[92,93],-97.32085,32.72541,{"lat":93,"lon":92},{"facility":96,"status":7,"city":97,"state":79,"zip":98,"country":20,"countryCode":21,"cosmosGeoPoint":99,"geoPoint":103,"contacts":7},"Park Plaza Hosp","Houston","77004",{"type":23,"coordinates":100},[101,102],-95.36327,29.76328,{"lat":102,"lon":101},"100054987","phase-2-phase-ii-study-of-the-safety-and-surrogate-marker-efficacy-of-butyldeoxynojirimycin-sc-48334-and-azt-in-symptomatic-hiv-1-infected-patients-with-200---500-cd4-cellsmm3-note-asymptomatic-hiv-1-infected-patients-also-eligible-100054987",false,"NCT00002079","Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells\u002Fmm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)","Inclusion Criteria\n\nPatients must have:\n\n* Documented HIV infection.\n* CD4 cell count 200 - 500 cells\u002Fmm3.\n* Prior therapy with 12 - 48 weeks of AZT.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Clinically significant diarrhea without definable cause (\\> 3 liquid stools per day for more than 7 days within 6 months prior to study entry).\n* Diarrhea, as above, with known non-HIV-related cause occurring within 1 month prior to study entry.\n* Symptoms meeting CDC criteria for AIDS classification.\n* Fever as a constitutional sign of HIV disease (\\> 38.5 degrees C persisting for more than 14 consecutive days or for more than 15 days in any given 30-day period prior to study entry).\n* Malignancies, other than basal cell carcinoma and Kaposi's sarcoma (provided patient has fewer than 10 Kaposi's sarcoma lesions, no non-skin lesions, and no requirement for systemic treatment).\n* Significant organ dysfunction.\n* Known hypersensitivity to SC-48334 or AZT or related compounds.\n\nConcurrent Medication:\n\nExcluded:\n\n* Any investigational drug other than SC-48334.\n* Any anti-HIV drug other than AZT.\n* Cancer chemotherapy.\n\nPatients with the following prior conditions are excluded:\n\n* History of cataracts or known increased risk of cataract formation.\n* Known hypersensitivity to SC-48334 or AZT or related compounds.\n* History of lactose intolerance.\n\nPrior Medication:\n\nExcluded:\n\n* Prior SC-48334.\n* Cancer chemotherapy within 6 months prior to study entry.\n* Treatment with any investigational drug or any drug with anti-HIV activity, other than AZT, within 30 days prior to study entry.\n\nPrior Treatment:\n\nExcluded:\n\nWhole-body irradiation within 6 months prior to study entry. Current use of illicit substances, or abuse of alcohol, which would limit compliance with the protocol.","ALL","18 Years","INTERVENTIONAL",[114],"PHASE2","To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells\u002Fmm3. To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+ cells\u002Fmm3, and to assess the pharmacokinetics of the two drugs, given separately and in combination.",[117],"HIV Infections",[13,119],"1-Deoxynojirimycin","COMPLETED","2005-06-23",{"date":123,"type":124},"2005-06-24","ESTIMATED",{"name":126,"class":6},"G D Searle",9]