Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000688
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
A Randomized Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Status:
COMPLETED
Status Verified Date:
1990-10
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 provide information about the usefulness and safety of giving injections of ganciclovir DHPG for treating peripheral cytomegalovirus CMV retinitis
CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG
CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG
Detailed Description:
CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG
Patients are randomly placed in one of two treatment groups In one group patients receive DHPG twice a day intravenously for 14 days followed by a daily dose for 14 weeks Patients in the other group the delayed-treatment group do not receive immediate treatment with DHPG Patients in both groups have regular ophthalmologic eye evaluations with retinal photographs to see if the retinitis is getting worse Patients in the delayed treatment group receive DHPG if this occurs
Patients are randomly placed in one of two treatment groups In one group patients receive DHPG twice a day intravenously for 14 days followed by a daily dose for 14 weeks Patients in the other group the delayed-treatment group do not receive immediate treatment with DHPG Patients in both groups have regular ophthalmologic eye evaluations with retinal photographs to see if the retinitis is getting worse Patients in the delayed treatment group receive DHPG if this occurs
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 1697 | None | None | None |
| RS-21592 | None | None | None |