Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000697
Status:
WITHDRAWN
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Foscarnet in the Treatment of Cytomegalovirus CMV of the Eyes in Patients With AIDS Who Cannot Use Ganciclovir
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 Randomized Controlled Trial of Immediate Versus Delayed Foscarnet Therapy in AIDS Patients With Non-Immediately Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due to Myelosuppression
Status:
WITHDRAWN
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 study the safety and effectiveness of foscarnet in the treatment of AIDS patients who have active infection with cytomegalovirus CMV that is causing inflammation of the retina retinitis In addition these patients cannot be treated with ganciclovir DHPG because of its toxic effect on the bodys blood-forming cells or because white blood cell or platelet counts were too low
CMV is a common virus which can cause blindness and death in AIDS patients Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection Although treatment with ganciclovir DHPG is also effective a significant toxicity leading to dose-limiting neutropenia low white blood cell count in one third of treated patients has been associated with the drug Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients the present study will evaluate the safety and efficacy of intravenous IV foscarnet in AIDS patients with CMV retinitis
CMV is a common virus which can cause blindness and death in AIDS patients Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection Although treatment with ganciclovir DHPG is also effective a significant toxicity leading to dose-limiting neutropenia low white blood cell count in one third of treated patients has been associated with the drug Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients the present study will evaluate the safety and efficacy of intravenous IV foscarnet in AIDS patients with CMV retinitis
Detailed Description:
CMV is a common virus which can cause blindness and death in AIDS patients Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection Although treatment with ganciclovir DHPG is also effective a significant toxicity leading to dose-limiting neutropenia low white blood cell count in one third of treated patients has been associated with the drug Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients the present study will evaluate the safety and efficacy of intravenous IV foscarnet in AIDS patients with CMV retinitis
Following routine evaluation studies patients are randomized to receive foscarnet right away or to delay treatment as their retinitis has been determined not to be immediately sight-threatening Patients are hospitalized for the first 3 days and may remain hospitalized for as many as 14 days Foscarnet is given by vein IV in what is called induction therapy and if the patients retinitis stabilizes after 2 weeks of treatment treatment with foscarnet is continued in maintenance therapy for another 8 weeks During maintenance therapy patients receive salt solution IV to help prevent any toxic side effect of foscarnet on the kidneys Patients have regular checkups to monitor their retinitis as well as their general health Patients taking zidovudine AZT prior to entering the study may continue their treatment if they are selected for the delayed treatment group if they are selected for the immediate treatment group they begin or resume AZT therapy when they enter the 2nd week of maintenance therapy Patients are followed as outpatients for at least 10 weeks with clinic check-ups and lab tests once every week eye exams are done once a week for the first 2 weeks and then every other week If clinically indicated a continued maintenance regimen may be administered after the 10th week the total duration of therapy plus maintenance is not to exceed 24 weeks Note Patients scheduled for the delayed foscarnet treatment are immediately given foscarnet at the first sign that their retinitis is getting worse
Following routine evaluation studies patients are randomized to receive foscarnet right away or to delay treatment as their retinitis has been determined not to be immediately sight-threatening Patients are hospitalized for the first 3 days and may remain hospitalized for as many as 14 days Foscarnet is given by vein IV in what is called induction therapy and if the patients retinitis stabilizes after 2 weeks of treatment treatment with foscarnet is continued in maintenance therapy for another 8 weeks During maintenance therapy patients receive salt solution IV to help prevent any toxic side effect of foscarnet on the kidneys Patients have regular checkups to monitor their retinitis as well as their general health Patients taking zidovudine AZT prior to entering the study may continue their treatment if they are selected for the delayed treatment group if they are selected for the immediate treatment group they begin or resume AZT therapy when they enter the 2nd week of maintenance therapy Patients are followed as outpatients for at least 10 weeks with clinic check-ups and lab tests once every week eye exams are done once a week for the first 2 weeks and then every other week If clinically indicated a continued maintenance regimen may be administered after the 10th week the total duration of therapy plus maintenance is not to exceed 24 weeks Note Patients scheduled for the delayed foscarnet treatment are immediately given foscarnet at the first sign that their retinitis is getting worse
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 |
|---|---|---|---|
| 11067 | REGISTRY | DAIDS ES Registry Number | None |