Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000698
Status:
COMPLETED
Last Update Posted:
2008-09-30
First Post:
1999-11-02
Brief Title:
A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Status:
COMPLETED
Status Verified Date:
1992-04
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 determine the safety and effectiveness of intravenous ganciclovir also known as DHPG in the treatment of sight-threatening cytomegalovirus CMV retinitis in patients with AIDS CMV retinitis is a severe vision-threatening viral infection of the retina of the eye It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS Ganciclovir GCV improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks but almost all of the patients treated with GCV had a relapse after treatment was stopped Thus it is important to determine if GCV can be safely given over a long period of time maintenance therapy and if it is effective in preventing a relapse of CMV retinitis
Detailed Description:
CMV retinitis is a severe vision-threatening viral infection of the retina of the eye It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS Ganciclovir GCV improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks but almost all of the patients treated with GCV had a relapse after treatment was stopped Thus it is important to determine if GCV can be safely given over a long period of time maintenance therapy and if it is effective in preventing a relapse of CMV retinitis
Patients are given GCV intravenously for 14 days Then the patient receives the same dose but only once a day for as long as therapy is tolerated If the retinitis worsens during the maintenance phase the patient may again be given GCV for 14 days Long-term treatment with GCV usually requires the surgical placement of a catheter in a large central vein in the chest or groin that is left in place indefinitely If this is required the procedure will be explained to the patient
Patients are given GCV intravenously for 14 days Then the patient receives the same dose but only once a day for as long as therapy is tolerated If the retinitis worsens during the maintenance phase the patient may again be given GCV for 14 days Long-term treatment with GCV usually requires the surgical placement of a catheter in a large central vein in the chest or groin that is left in place indefinitely If this is required the procedure will be explained to the patient
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?: