Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000687
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposis Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposis Sarcoma
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 determine the safety and effectiveness of combining zidovudine AZT and interferon alfa-2a IFN-A2a in a treatment for Kaposis sarcoma KS in patients who have AIDS It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time
In a recent study the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined In addition it appeared that there was a substantial reduction in KS lesions with this therapy Potential benefits of this combined therapy include resolution of KS lesions prolonged survival a decrease in the frequency and severity of opportunistic infections improvement in CD4 cells and a decrease in serum p24 antigens
In a recent study the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined In addition it appeared that there was a substantial reduction in KS lesions with this therapy Potential benefits of this combined therapy include resolution of KS lesions prolonged survival a decrease in the frequency and severity of opportunistic infections improvement in CD4 cells and a decrease in serum p24 antigens
Detailed Description:
In a recent study the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined In addition it appeared that there was a substantial reduction in KS lesions with this therapy Potential benefits of this combined therapy include resolution of KS lesions prolonged survival a decrease in the frequency and severity of opportunistic infections improvement in CD4 cells and a decrease in serum p24 antigens
Following evaluation studies patients who participate in the study receive IFN-A2a and AZT IFN-A2a is administered as a single subcutaneous injection once a day AZT is given in a single capsule every 4 hours through the day for a total of six capsules The first phase of treatment continues for 8 weeks followed by a 1-week rest period during which time AZT only is given Subjects who have had an interruption in interferon during the first 8 weeks of the study for a toxicity may skip the rest period Patients experiencing a complete response will be placed on maintenance therapy Patients without progression of their KS can continue on the treatment of AZT and IFN-A2a until a complete response is obtained or until study is terminated whichever comes first Patients with complete anti-tumor response can continue on a maintenance phase in which they receive IFN-A2a as a single injection 3 times a week on nonconsecutive days and a single capsule of AZT q4h 6 x day until the study is terminated on February 1 1992 Patients are required to visit the clinic weekly for the first 12 weeks except during the week 9 rest period every other week for the next 8 weeks every month for up to 52 weeks of the study and every 3 months thereafter Throughout the study frequent blood samples will be taken to monitor the effectiveness and safety of the treatment
Following evaluation studies patients who participate in the study receive IFN-A2a and AZT IFN-A2a is administered as a single subcutaneous injection once a day AZT is given in a single capsule every 4 hours through the day for a total of six capsules The first phase of treatment continues for 8 weeks followed by a 1-week rest period during which time AZT only is given Subjects who have had an interruption in interferon during the first 8 weeks of the study for a toxicity may skip the rest period Patients experiencing a complete response will be placed on maintenance therapy Patients without progression of their KS can continue on the treatment of AZT and IFN-A2a until a complete response is obtained or until study is terminated whichever comes first Patients with complete anti-tumor response can continue on a maintenance phase in which they receive IFN-A2a as a single injection 3 times a week on nonconsecutive days and a single capsule of AZT q4h 6 x day until the study is terminated on February 1 1992 Patients are required to visit the clinic weekly for the first 12 weeks except during the week 9 rest period every other week for the next 8 weeks every month for up to 52 weeks of the study and every 3 months thereafter Throughout the study frequent blood samples will be taken to monitor the effectiveness and safety of the treatment
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 |
|---|---|---|---|
| 11071 | REGISTRY | DAIDS ES Registry Number | None |