[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054924":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":12,"responsibleParty":7,"collaborators":7,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":7,"eligibilityCriteria":41,"healthyVolunteers":38,"sex":42,"minAge":43,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":51,"overallStatus":58,"whyStopped":7,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":63,"locationsCount":65},{"fullName":5,"class":6},"NIH AIDS Clinical Trials Information Service","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Sevirumab",[13,26],{"facility":14,"status":7,"city":15,"state":16,"zip":17,"country":18,"countryCode":19,"cosmosGeoPoint":20,"geoPoint":25,"contacts":7},"Harvard (Massachusetts Gen Hosp)","Boston","Massachusetts","02114","United States","US",{"type":21,"coordinates":22},"Point",[23,24],-71.05977,42.35843,{"lat":24,"lon":23},{"facility":27,"status":7,"city":28,"state":29,"zip":30,"country":18,"countryCode":19,"cosmosGeoPoint":31,"geoPoint":35,"contacts":7},"Univ TX Galveston Med Branch","Galveston","Texas","77550",{"type":21,"coordinates":32},[33,34],-94.7977,29.30135,{"lat":34,"lon":33},"100054924","phase-1-a-phase-iii-trial-to-assess-the-safety-and-tolerance-of-escalating-doses-of-a-human-anti-cytomegalovirus-monoclonal-antibody-sdz-msl-109-in-patients-with-the-acquired-immunodeficiency-syndrome-and-cmv-retinitis-100054924",false,"NCT00002016","A Phase I\u002FII Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine (AZT) \\\u003C 600 mg\u002Fday.\n* Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection.\n* Trimethoprim \u002F sulfamethoxazole (TMP \u002F SMX).\n* Pyrimethamine \u002F sulfadoxine.\n* Aerosolized pentamidine.\n* Ketoconazole.\n* Flucytosine (5-FC).\n* Antituberculosis therapy.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Maintenance phase of ganciclovir (DHPG) therapy.\n\nPatients must have:\n\n* AIDS with documented ophthalmologic findings consistent with cytomegalovirus (CMV) retinitis whose retinal lesions are less than 750 microns from the fovea and who have visual symptoms of CMV retinitis.\n* Completed the treatment induction phase with ganciclovir (DHPG) and be about to participate in the maintenance phase DHPG therapy.\n* Expected survival of = or \\> 6 months.\n* Willingness and ability to give written informed consent. A copy of the signed and witnessed consent form must be maintained with the investigator's study files.\n* Seropositive for the presence of circulating anti-CMV immunoglobulin.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Significant pulmonary dysfunction.\n* Uncontrolled or unstable diabetes.\n* Significant cardiovascular disease including uncontrolled hypertension, congestive heart failure, cardiac arrhythmia, angina pectoris, or a history of myocardial infarction within one year of entry into the study.\n* Coagulation or hemorrhagic disorders.\n* Any active severe opportunistic infection.\n\nConcurrent Medication:\n\nExcluded:\n\n* Therapy with amphotericin B or fluconazole.\n* Any other investigational drug.\n* Biologicals including immunoglobulin therapy, granulocyte-macrophage-colony-stimulating-factor (GM-CSF), erythropoietin alpha, or any interleukin.\n\nPatients with the following are excluded:\n\n* Any significant organ system dysfunction as described in Exclusion Co-existing Conditions.\n* Any other severe concomitant clinical condition.\n\nPrior Medication:\n\nExcluded within 2 weeks of study entry:\n\n* Therapy with amphotericin B or fluconazole.\n* Any other investigational drug.\n* Biologicals including immunoglobulin therapy, granulocyte-macrophage-colony-stimulating factor (GM-CSF), erythropoietin alpha, or any interleukin.\n* Excluded:\n* Prior treatment with monoclonal antibodies derived from any animal species.\n\nPrior Treatment:\n\nExcluded within 2 weeks of study entry:\n\n* Major surgery.","ALL","18 Years","INTERVENTIONAL",[46],"PHASE1","To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and documented evidence of CMV retinitis. In addition for those patients with positive CMV cultures upon entry into this trial a preliminary attempt will be made to assess the potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ MSL-109.",[49,50],"Cytomegalovirus Retinitis","HIV Infections",[52,53,54,55,56,57],"Retinitis","Ganciclovir","Cytomegalovirus","Cytomegalovirus Infections","Acquired Immunodeficiency Syndrome","Antibodies, Monoclonal","COMPLETED","2005-06-23",{"date":61,"type":62},"2005-06-24","ESTIMATED",{"name":64,"class":6},"Sandoz",2]