Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000691
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase II Dose-Ranging Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Dose-Ranging Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
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 examine the usefulness and safety of the antiviral drug foscarnet in treating AIDS patients with cytomegalovirus CMV infection that is causing sight-threatening inflammation of the retina in one or both eyes CMV retinitis Because of the seriousness of sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for those patients who cannot be treated with ganciclovir DHPG because of its toxic effect on the bodys blood-forming cells because it did not control the disease or because patients blood cell or platelet counts are too low to begin with it is worthwhile to try an immediate trial with foscarnet AMENDED ACTG 093 was originally designed as a randomized dose-ranging study of foscarnet maintenance therapy Patients enrolled between March 17 1989 and January 1 1990 received either 60 mgkgday or 90mgkg day as maintenance therapy following the 2 week induction period Based on the preliminary results of ACTG 015915 which studied maintenance doses of foscarnet of 60 mgkgday 90 mgkgday and 120 mgkgday the 60-mgkgday and 90mgkgday arms of this study have been closed All patients entering the study beginning January 2 1990 will receive foscarnet maintenance therapy on a 120mgkgday algorithm following induction
Detailed Description:
Because of the seriousness of sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for those patients who cannot be treated with ganciclovir DHPG because of its toxic effect on the bodys blood-forming cells because it did not control the disease or because patients blood cell or platelet counts are too low to begin with it is worthwhile to try an immediate trial with foscarnet AMENDED ACTG 093 was originally designed as a randomized dose-ranging study of foscarnet maintenance therapy Patients enrolled between March 17 1989 and January 1 1990 received either 60 mgkgday or 90mgkg day as maintenance therapy following the 2 week induction period Based on the preliminary results of ACTG 015915 which studied maintenance doses of foscarnet of 60 mgkgday 90 mgkgday and 120 mgkgday the 60-mgkgday and 90mgkgday arms of this study have been closed All patients entering the study beginning January 2 1990 will receive foscarnet maintenance therapy on a 120mgkgday algorithm following induction
AMENDED The ACTG 093 optional extended maintenance therapy period will conclude on January 2 1991 in order to facilitate timely analysis of this study All patients who wish to continue foscarnet therapy should be referred to Astra Protocol 90-FOS-14 at telephone number 800-292-5775 Original design Patients are placed into two groups 1 patients who have a sight-threatening lesion in the retina of an eye with vision that can be saved corrected vision of 20100 or better and who cannot be treated with DHPG and 2 patients whose retinitis has quickly gotten worse andor has shown resistance to DHPG treatment Both groups will receive a beginning induction dose of foscarnet by vein IV for 2 weeks followed by a maintenance dose for 8 weeks with an option to continue up to 24 weeks AMENDED Patients entering the study on or after 010290 receive the standard two week course of foscarnet induction therapy and receive maintenance therapy Treatment is given for a ten week study period or until progression occurs or toxicity endpoints are reached If retinitis is stable and foscarnet well-tolerated maintenance therapy may be extended for a period not to exceed 1 year
AMENDED The ACTG 093 optional extended maintenance therapy period will conclude on January 2 1991 in order to facilitate timely analysis of this study All patients who wish to continue foscarnet therapy should be referred to Astra Protocol 90-FOS-14 at telephone number 800-292-5775 Original design Patients are placed into two groups 1 patients who have a sight-threatening lesion in the retina of an eye with vision that can be saved corrected vision of 20100 or better and who cannot be treated with DHPG and 2 patients whose retinitis has quickly gotten worse andor has shown resistance to DHPG treatment Both groups will receive a beginning induction dose of foscarnet by vein IV for 2 weeks followed by a maintenance dose for 8 weeks with an option to continue up to 24 weeks AMENDED Patients entering the study on or after 010290 receive the standard two week course of foscarnet induction therapy and receive maintenance therapy Treatment is given for a ten week study period or until progression occurs or toxicity endpoints are reached If retinitis is stable and foscarnet well-tolerated maintenance therapy may be extended for a period not to exceed 1 year
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 |
|---|---|---|---|
| 11068 | REGISTRY | DAIDS ES Registry Number | None |