[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100055208":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":12,"responsibleParty":7,"collaborators":7,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":7,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":7,"targetDuration":7,"studyType":36,"phases":37,"briefSummary":39,"conditions":40,"keywords":43,"overallStatus":51,"whyStopped":7,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":56,"locationsCount":58},{"fullName":5,"class":6},"NIH AIDS Clinical Trials Information Service","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Foscarnet sodium",[13],{"facility":14,"status":7,"city":15,"state":16,"zip":17,"country":18,"countryCode":19,"cosmosGeoPoint":20,"geoPoint":25,"contacts":7},"Foscarnet Research Program \u002F Park Plaza Hosp","Houston","Texas","77004","United States","US",{"type":21,"coordinates":22},"Point",[23,24],-95.36327,29.76328,{"lat":24,"lon":23},"100055208","a-study-of-foscarnet-in-the-treatment-of-cytomegalovirus-cmv-of-the-eyes-in-patients-with-aids-who-have-not-had-success-with-ganciclovir-100055208",false,"NCT00002301","A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Have Not Had Success With Ganciclovir","Foscarnet Treatment of Cytomegalovirus (CMV) Retinitis in AIDS Patients Not Eligible for Ganciclovir Therapy and Ganciclovir Treatment Failures","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Ganciclovir.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Known allergy to foscarnet.\n* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).\n* Corneal, lens, or vitreous opacification which precludes examination of the fundi in patients with cytomegalovirus (CMV) retinitis.\n\nConcurrent Medication:\n\nExcluded:\n\n* Acyclovir.\n* Nephrotoxic agent.\n\nPatients with the following are excluded:\n\n* Known allergy to foscarnet.\n* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).\n* Corneal, lens, or vitreous opacification which precludes examination of the fundi in patients with CMV retinitis.\n\nPrior Medication:\n\nExcluded within 7 days of study entry:\n\n* Immunomodulators.\n* Biologic response modifiers.\n* Investigational agents.\n\nAIDS patients experiencing cytomegalovirus (CMV) retinitis may be enrolled if they meet one of the following criteria:\n\n* Myelosuppression:\n* Previously suffered severe dose-limiting ganciclovir-related myelosuppression, or are ineligible for ganciclovir treatment due to myelosuppression.\n* Ganciclovir treatment failure:\n* Clearly failed to have a therapeutic response to ganciclovir therapy.\n* Patients must be able to give informed consent.\n* Patients presenting with a baseline absolute neutrophil count \\\u003C 750 cells\u002Fmm3 or baseline platelet count \\\u003C 50000 platelets\u002Fmm3 will be categorized as ineligible to receive ganciclovir induction therapy and will be allowed to enter the study.\n* Patients who enter the study because of ganciclovir toxicity will have received ganciclovir therapy which resulted in either absolute neutrophil count falling to \\\u003C 750 cells\u002Fmm3 or platelet count falling to \\\u003C 50000 platelets\u002Fmm3 on two separate occasions during either\n\n  1\\) a ganciclovir induction regimen of 7.5 mg or less ganciclovir\u002Fkg\u002Fday in divided doses or 2) a maintenance regimen of 5 mg or less ganciclovir\u002Fkg\u002Fday as a single dose.\n* Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria:\n* 1\\) CMV retinitis progression as defined in section V.C.1., i.e., has occurred either at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10.0 mg\u002Fkg\u002Fday in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 or more mg\u002Fkg\u002Fday in at least 5 days\u002Fweek) where maintenance therapy began within\n\n  1. week of completing induction therapy.","ALL","18 Years","65 Years","INTERVENTIONAL",[38],"NA","To evaluate the safety and efficacy of foscarnet induction treatment of cytomegalovirus (CMV) retinitis in AIDS patients who have previously suffered severe dose-limiting ganciclovir-related myelosuppression, who are ineligible for ganciclovir treatment due to myelosuppression or who have clearly failed to have a therapeutic response to ganciclovir therapy. To assess the duration of clinical response. To evaluate the effect on quantitative CMV cultures of blood and urine. To determine the effect on recovery of HIV p24 antigen capture direct from plasma.",[41,42],"Cytomegalovirus Retinitis","HIV Infections",[44,45,46,47,48,49,50],"Retinitis","AIDS-Related Opportunistic Infections","Ganciclovir","Foscarnet","Cytomegalovirus Infections","Acquired Immunodeficiency Syndrome","Antiviral Agents","UNKNOWN","2005-06-23",{"date":54,"type":55},"2005-06-24","ESTIMATED",{"name":57,"class":6},"Astra USA",1]