[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054907":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":14,"responsibleParty":7,"collaborators":7,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":7,"eligibilityCriteria":33,"healthyVolunteers":30,"sex":34,"minAge":35,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":36,"phases":37,"briefSummary":39,"conditions":40,"keywords":43,"overallStatus":50,"whyStopped":7,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":55,"locationsCount":58},{"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","Globulin, Immune",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"Ganciclovir",[15],{"facility":16,"status":7,"city":17,"state":18,"zip":19,"country":20,"countryCode":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":7},"Georgetown Univ Med Ctr","Washington D.C.","District of Columbia","20007","United States","US",{"type":23,"coordinates":24},"Point",[25,26],-77.03637,38.89511,{"lat":26,"lon":25},"100054907","a-pilot-study-to-obtain-preliminary-information-regarding-the-efficacy-and-safety-of-the-combination-of-immune-globulin-and-ganciclovir-as-compared-to-ganciclovir-alone-in-the-treatment-of-sight-threatening-cmv-retinitis-in-patients-with-aids-100054907",false,"NCT00001999","A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS","Inclusion Criteria\n\nPatients must have the following:\n\n* First episode of sight-threatening CMV retinitis.\n* At least one pending culture for CMV from the blood or urine prior to entry.\n* Life expectancy \\> 6 months.\n* Karnofsky performance = or \\> 60.\n* Ability to understand the nature of the study, to comply with study requirements, and to sign informed consent.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions are excluded:\n\n* Known selective IGA deficiency or antibodies against IgA.\n* History of previous episodes of sight-threatening CMV retinitis.\n\nPatients with the following are excluded:\n\n* Previous episode of sight-threatening CMV retinitis.\n* Concomitant treatment with other investigational agents except ddI or ddC.\n* Life expectancy \\\u003C 6 months.\n* Continued alcohol or drug abuse.\n* Known selective IgA deficiency and known to have antibodies against IgA.\n* Karnofsky performance \\\u003C60.\n\nOther investigational agents except ddI or ddC.\n\nddI ddC","ALL","18 Years","INTERVENTIONAL",[38],"NA","To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a difference between the two groups in regard to survival, immune functions, and CMV viremia and viruria.",[41,42],"Cytomegalovirus Retinitis","HIV Infections",[44,45,13,46,47,48,49],"Retinitis","Gamma-Globulins","Drug Therapy, Combination","Cytomegalovirus Infections","Acquired Immunodeficiency Syndrome","Immunization, Passive","COMPLETED","2005-06-23",{"date":53,"type":54},"2005-06-24","ESTIMATED",{"name":56,"class":57},"American National Red Cross","OTHER",1]