Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002145
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Phase III Multicenter Open-Label Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet Foscavir Therapy for Gastrointestinal CMV Disease
Sponsor:
Astra USA
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Phase III Multicenter Open-Label Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet Foscavir Therapy for Gastrointestinal CMV Disease
Status:
COMPLETED
Status Verified Date:
1996-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PRIMARY To compare the frequency of and time to relapse of Cytomegalovirus CMV gastrointestinal disease following foscarnet induction therapy only versus induction plus maintenance therapy
SECONDARY To determine frequency of and time to recurrence of gastrointestinal symptoms response rate of pathological lesions and incidence of nongastrointestinal CMV disease in this patient population
SECONDARY To determine frequency of and time to recurrence of gastrointestinal symptoms response rate of pathological lesions and incidence of nongastrointestinal CMV disease in this patient population
Detailed Description:
Patients receive intravenous foscarnet either as induction only for 4 weeks or as induction for 4 weeks followed by maintenance for 22 weeks All patients are followed for 26 weeks or until relapse
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-FOS-29 | None | None | None |