Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001034
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus CMV of the Eyes and Disease of the Stomach and Intestines in Patients With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Comparative Placebo-Controlled Trial of the Safety and Efficacy of Oral Ganciclovir for Prophylaxis of Cytomegalovirus CMV Retinal and Gastrointestinal Mucosal Disease in HIV-Infected Individuals With Severe Immunosuppression
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus CMV retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression
The most recent treatments against CMV disease have been ganciclovir and foscarnet Until recently both drugs required intravenous administration An oral form of ganciclovir if shown to be effective therapy against CMV would be a more suitable method of administration for prophylaxis
The most recent treatments against CMV disease have been ganciclovir and foscarnet Until recently both drugs required intravenous administration An oral form of ganciclovir if shown to be effective therapy against CMV would be a more suitable method of administration for prophylaxis
Detailed Description:
The most recent treatments against CMV disease have been ganciclovir and foscarnet Until recently both drugs required intravenous administration An oral form of ganciclovir if shown to be effective therapy against CMV would be a more suitable method of administration for prophylaxis
Patients are randomized in a 21 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months PER AMENDMENT 91994 Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir PER AMENDMENT 5295 After the common closing date 6395 patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 83195
Patients are randomized in a 21 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months PER AMENDMENT 91994 Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir PER AMENDMENT 5295 After the common closing date 6395 patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 83195
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 |
|---|---|---|---|
| 11573 | REGISTRY | DAIDS ES Registry Number | None |