[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100055175":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":56,"whyStopped":7,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":61,"locationsCount":63},{"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},"Univ of Alabama at Birmingham","Birmingham","Alabama","35294","United States","US",{"type":21,"coordinates":22},"Point",[23,24],-86.80249,33.52066,{"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},"100055175","phase-1-a-randomized-phase-iii-trial-to-assess-the-safety-and-antiviral-effects-of-escalating-doses-of-a-human-anti-cytomegalovirus-monoclonal-antibody-sdz-msl-109-in-patients-with-the-acquired-immunodeficiency-syndrome-and-cmv-viremia-andor-viruria-100055175",false,"NCT00002268","A Randomized, Phase I\u002FII Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and\u002For Viruria","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine (AZT).\n* Acyclovir.\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* Inhaled pentamidine.\n* Amphotericin B.\n* Ketoconazole.\n* Flucytosine (5-FC).\n* Antituberculosis therapy.\n* Recombinant human erythropoietin.\n* Recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF).\n* Recombinant human interferon alfa 2 for AIDS-related Kaposi's sarcoma.\n\nPatients must have:\n\n* AIDS or be HIV positive with CD4 lymphocyte counts below 200 cells\u002Fmm3 and be receiving prophylaxis for Pneumocystis carinii pneumonia (PCP) (with or without prophylaxis for another opportunistic infection), but have no prior medical history of an opportunistic infection.\n* Expected survival of = or \\> 6 months.\n* Willingness and ability to give written informed consent.\n* A copy of the signed and witnessed consent form must be maintained with the investigator's study files.\n* Positive culture results documenting the presence of cytomegalovirus (CMV) viremia and\u002For viruria.\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 ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol.\n* Any other experimental antiviral therapy.\n* Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol).\n\nPatients with the following are excluded:\n\n* Any significant organ system dysfunction as described in Exclusion co-existing conditions.\n* Previous history of or evidence of idiopathic thrombocytopenia purpura, agammaglobulinemia, or hypogammaglobulinemia.\n* Any other severe concomitant clinical condition.\n* Documented, active cytomegalovirus (CMV) disease (tissue or organ invasion\u002Fdysfunction) at baseline. To this end, baseline indirect funduscopy (to detect and exclude patients with peripheral CMV retinitis) will be performed.\n\nPrior Medication:\n\nExcluded within 2 weeks of study entry:\n\n* Therapy with ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol.\n* Any other experimental antiviral therapy.\n* Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol).\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, tolerance, and potential in vivo antiviral effects of five dosage levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109; formerly SDZ 89-109) when administered once every 2 weeks for a total of 12 doses to patients with either AIDS or eligible AIDS-related complex (ARC) and with culture proven evidence of CMV viremia and\u002For viruria. Sandoglobulin will be employed as a comparative control.",[49,50],"Cytomegalovirus Infections","HIV Infections",[52,53,54,49,55],"AIDS-Related Opportunistic Infections","Immunotherapy","Drug Evaluation","Antibodies, Monoclonal","COMPLETED","2005-06-23",{"date":59,"type":60},"2005-06-24","ESTIMATED",{"name":62,"class":6},"Sandoz",2]