Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000673
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
1999-11-02
Brief Title:
A Phase III Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
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:
AMENDED 04-12-91 Population of patients changed FROM those who are intolerant of systemic therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of systemic therapy with CMV retinitis
AMENDED 8890 Changes made in neutrophils count from 500 to 750 cellsmm3 Nonrandomized eyes will not be used for the primary efficacy evaluation
ORIGINAL DESIGN To determine the effectiveness and safety of ganciclovir DHPG therapy in AIDS patients suffering from active cytomegalovirus CMV infection of the retina of the eye retinitis when the drug is administered directly into the fluid-filled vitreous cavity of the eye by injection
CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients and left untreated can lead to severe visual loss and blindness While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis the chronic administration required may be complicated by decreased blood cell counts granulocytopenia which may require discontinuation of treatment While withholding treatment may allow recovery from the granulocytopenia interruption of therapy may result in reactivation of the retinitis Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis
AMENDED 8890 Changes made in neutrophils count from 500 to 750 cellsmm3 Nonrandomized eyes will not be used for the primary efficacy evaluation
ORIGINAL DESIGN To determine the effectiveness and safety of ganciclovir DHPG therapy in AIDS patients suffering from active cytomegalovirus CMV infection of the retina of the eye retinitis when the drug is administered directly into the fluid-filled vitreous cavity of the eye by injection
CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients and left untreated can lead to severe visual loss and blindness While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis the chronic administration required may be complicated by decreased blood cell counts granulocytopenia which may require discontinuation of treatment While withholding treatment may allow recovery from the granulocytopenia interruption of therapy may result in reactivation of the retinitis Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis
Detailed Description:
CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients and left untreated can lead to severe visual loss and blindness While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis the chronic administration required may be complicated by decreased blood cell counts granulocytopenia which may require discontinuation of treatment While withholding treatment may allow recovery from the granulocytopenia interruption of therapy may result in reactivation of the retinitis Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis
Patients must have active CMV retinitis in one or both eyes despite prior systemic therapy Following medical evaluation the decision is made whether to treat the eyes immediately or to watch the eyes carefully for advancement of the retinitis Eyes with sight-threatening lesions or eyes without functional vision are treated immediately and eyes without sight-threatening lesions are randomly chosen for either immediate or deferred therapy DHPG is given by injection with a very fine needle twice a week for the first 3 weeks and once a week for the remaining 24 weeks
Patients must have active CMV retinitis in one or both eyes despite prior systemic therapy Following medical evaluation the decision is made whether to treat the eyes immediately or to watch the eyes carefully for advancement of the retinitis Eyes with sight-threatening lesions or eyes without functional vision are treated immediately and eyes without sight-threatening lesions are randomly chosen for either immediate or deferred therapy DHPG is given by injection with a very fine needle twice a week for the first 3 weeks and once a week for the remaining 24 weeks
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 |
|---|---|---|---|
| 11060 | REGISTRY | DAIDS ES Registry Number | None |