Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002247
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
Status:
COMPLETED
Status Verified Date:
1993-03
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:
To compare the safety and tolerance of oral ganciclovir at a double dose 3 timesday or a single dose 6 timesday to IV ganciclovir given for 20 weeks of maintenance therapy To compare the time to progression of cytomegalovirus CMV retinitis between two regimens of oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy To describe the efficacy and safety of double dose versus single dose oral ganciclovir in patients who have a progression of retinitis while on the originally assigned maintenance treatment To describe the safety tolerance and time to progression of retinitis during the 52 weeks of oral ganciclovir maintenance therapy in people with AIDS To describe the safety and tolerance of oral ganciclovir maintenance therapy when given concurrently with antiretroviral treatment eg zidovudine ddI or ddC To describe survival of people with AIDS and CMV retinitis
Detailed Description:
Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A B and C of the study provided that each subject has received and tolerated a therapeutic course of intravenous IV ganciclovir of at least 4 weeks duration resulting in stable retinitis An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research and have stable retinitis may enter into Group D of this study and receive oral ganciclovir
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 |
|---|---|---|---|
| ICM 1774 | None | None | None |