Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000694
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor rHuGM-CSF Recombinant Alpha Interferon and Azidothymidine AZT in 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:
A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor rHuGM-CSF Recombinant Alpha Interferon and Azidothymidine AZT in 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 define the best doses of sargramostim granulocyte-macrophage colony-stimulating factor GM-CSF interferon alfa-2b IFN-A2b and zidovudine AZT to give together in patients with AIDS-associated Kaposis sarcoma KS to learn about the side effects of these drugs when they are given together for 8 weeks and to find out whether the combination of GM-CSF IFN-A2b and AZT has any effect on KS HIV or the immune system
Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of patients IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and perhaps in patients AZT has also been shown to reduce the growth of HIV and show improvements in the immune system with fewer infections Test tube experiments show that when IFN-A2b and AZT are used together they reduce the growth of the HIV virus much more effectively than when either drug is used alone In recent studies of the combination of interferon alpha and AZT in patients with KS more than 40 percent of the patients showed shrinkage of their tumors and some showed evidence for suppression of HIV growth in the body However the combination of IFN-A2b with AZT often caused a marked lowering of the white blood cell WBC count especially a type of WBC called the granulocyte or neutrophil which is important in the bodys defense against infection Recombinant human GM-CSF is a human protein which is produced in bacteria It has been shown to cause an increase in the WBC count
Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of patients IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and perhaps in patients AZT has also been shown to reduce the growth of HIV and show improvements in the immune system with fewer infections Test tube experiments show that when IFN-A2b and AZT are used together they reduce the growth of the HIV virus much more effectively than when either drug is used alone In recent studies of the combination of interferon alpha and AZT in patients with KS more than 40 percent of the patients showed shrinkage of their tumors and some showed evidence for suppression of HIV growth in the body However the combination of IFN-A2b with AZT often caused a marked lowering of the white blood cell WBC count especially a type of WBC called the granulocyte or neutrophil which is important in the bodys defense against infection Recombinant human GM-CSF is a human protein which is produced in bacteria It has been shown to cause an increase in the WBC count
Detailed Description:
Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of patients IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and perhaps in patients AZT has also been shown to reduce the growth of HIV and show improvements in the immune system with fewer infections Test tube experiments show that when IFN-A2b and AZT are used together they reduce the growth of the HIV virus much more effectively than when either drug is used alone In recent studies of the combination of interferon alpha and AZT in patients with KS more than 40 percent of the patients showed shrinkage of their tumors and some showed evidence for suppression of HIV growth in the body However the combination of IFN-A2b with AZT often caused a marked lowering of the white blood cell WBC count especially a type of WBC called the granulocyte or neutrophil which is important in the bodys defense against infection Recombinant human GM-CSF is a human protein which is produced in bacteria It has been shown to cause an increase in the WBC count
AMENDED 900910 to allow one patient to be treated beyond one year Original design GM-CSF IFN-A2b and AZT are given every day for 8 weeks There are 6 patients per dose level IFN-A2b and GM-CSF are given in two separate injections under the skin subcutaneous injection once a day AZT is given orally every 4 hours 6 timesday The first patients are given doses of the drugs that are quite well tolerated when given alone If these dosages are tolerated without serious side effects the dosage of IFN-A2b is increased in subsequent groups of patients Maintenance treatment consisting of the same dose received at the conclusion of the initial 8 week course of treatment will be resumed with eligible patients for up to 1 year
AMENDED 900910 to allow one patient to be treated beyond one year Original design GM-CSF IFN-A2b and AZT are given every day for 8 weeks There are 6 patients per dose level IFN-A2b and GM-CSF are given in two separate injections under the skin subcutaneous injection once a day AZT is given orally every 4 hours 6 timesday The first patients are given doses of the drugs that are quite well tolerated when given alone If these dosages are tolerated without serious side effects the dosage of IFN-A2b is increased in subsequent groups of patients Maintenance treatment consisting of the same dose received at the conclusion of the initial 8 week course of treatment will be resumed with eligible patients for up to 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 |
|---|---|---|---|
| 11065 | REGISTRY | DAIDS ES Registry Number | None |