Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001112
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine
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 Study To Determine the Safety of the Optimal Monocyte Activating Administration Schedule of Subcutaneous Human Recombinant Interferon-gamma in ZDV-Treated Patients With AIDS
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 find out which of four doses of recombinant human interferon gamma IFN-G is most effective in stimulating the white blood cells monocytes to fight infection and to see if treatment with IFN-G can strengthen the ability of AIDS patients to control infections This study will also determine how long after a single injection of IFN-G white blood cells remain stimulated
AIDS is a disease that progressively destroys that aspect of the bodys defense called the immune system It is particularly harmful to a class of cells called helper T-lymphocytes The specific opportunistic infections and malignancies associated with AIDS have been treated with therapies that are often poorly tolerated by the patients and are associated with dose-limiting toxicities The principal focus of AIDS therapy research at present is to control the underlying retroviral infection and to restore immune function with recombinant lymphokines adoptive immunotherapy andor lymphocyte transplants These treatments include zidovudine AZT which has been shown to control the HIV infection and IFN-G a lymphokine which activates tumor-destroying and germ-killing functions Studies are needed to find the dose by which IFN-G works best
AIDS is a disease that progressively destroys that aspect of the bodys defense called the immune system It is particularly harmful to a class of cells called helper T-lymphocytes The specific opportunistic infections and malignancies associated with AIDS have been treated with therapies that are often poorly tolerated by the patients and are associated with dose-limiting toxicities The principal focus of AIDS therapy research at present is to control the underlying retroviral infection and to restore immune function with recombinant lymphokines adoptive immunotherapy andor lymphocyte transplants These treatments include zidovudine AZT which has been shown to control the HIV infection and IFN-G a lymphokine which activates tumor-destroying and germ-killing functions Studies are needed to find the dose by which IFN-G works best
Detailed Description:
AIDS is a disease that progressively destroys that aspect of the bodys defense called the immune system It is particularly harmful to a class of cells called helper T-lymphocytes The specific opportunistic infections and malignancies associated with AIDS have been treated with therapies that are often poorly tolerated by the patients and are associated with dose-limiting toxicities The principal focus of AIDS therapy research at present is to control the underlying retroviral infection and to restore immune function with recombinant lymphokines adoptive immunotherapy andor lymphocyte transplants These treatments include zidovudine AZT which has been shown to control the HIV infection and IFN-G a lymphokine which activates tumor-destroying and germ-killing functions Studies are needed to find the dose by which IFN-G works best
Patients who may participate in all three parts of the study are maintained on a stable dose of AZT In part A optimal dose five AIDS patients who have had an AIDS related opportunistic infection receive 4 once-weekly increasing doses of IFN-G Monocyte antimicrobial activity is examined in test tube studies before and after each injection of IFN-G In part B five patients receive the optimal dose of IFN-G established in part A Patients enrolled from part A have completed at least 2 weeks of part A before enrolling in part B Antimicrobial activity is examined 1 2 and 3 days after a single injection of the optimal dose of IFN-G determined in part A In part C safety and tolerance of combined treatment of IFN-G and AZT patients are treated with IFN-G for 4 weeks using the optimal dose and administration schedule derived from parts A and B
Patients who may participate in all three parts of the study are maintained on a stable dose of AZT In part A optimal dose five AIDS patients who have had an AIDS related opportunistic infection receive 4 once-weekly increasing doses of IFN-G Monocyte antimicrobial activity is examined in test tube studies before and after each injection of IFN-G In part B five patients receive the optimal dose of IFN-G established in part A Patients enrolled from part A have completed at least 2 weeks of part A before enrolling in part B Antimicrobial activity is examined 1 2 and 3 days after a single injection of the optimal dose of IFN-G determined in part A In part C safety and tolerance of combined treatment of IFN-G and AZT patients are treated with IFN-G for 4 weeks using the optimal dose and administration schedule derived from parts A and B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11046 | REGISTRY | DAIDS ES Registry ID | None |