Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001004
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients With AIDS Related Complex
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Multicenter Phase II Trial of Recombinant Tumor Necrosis Factor and Recombinant Human Interferon-gamma in Patients With AIDS Related Complex
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 study the tolerance and toxicity of the combination of tumor necrosis factor TNF and interferon gamma IFN-G or as single agent TNF or IFN-G in HIV infected patients To selectively monitor the immune system of AIDS related complex ARC patients who receive either combination therapy or TNF or IFN-G alone To obtain information on the effectiveness of combination therapy or TNF or IFN-G alone against HIV in ARC patients
Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which causes AIDS and ARC in some laboratory studies but may increase virus replication in other laboratory studies Previous studies in humans showed no increase in virus cultures and some decrease in measurements of virus Extensive preclinical data show that TNF and IFN-G are more effective together than separately in laboratory and animal studies As single agents both TNF and IFN-G have modest effect against HIV Studies have demonstrated that TNF and IFN-G in combination can not only inhibit HIV infection of previously uninfected cells but also can selectively induce the destruction of acutely infected target cells
Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which causes AIDS and ARC in some laboratory studies but may increase virus replication in other laboratory studies Previous studies in humans showed no increase in virus cultures and some decrease in measurements of virus Extensive preclinical data show that TNF and IFN-G are more effective together than separately in laboratory and animal studies As single agents both TNF and IFN-G have modest effect against HIV Studies have demonstrated that TNF and IFN-G in combination can not only inhibit HIV infection of previously uninfected cells but also can selectively induce the destruction of acutely infected target cells
Detailed Description:
Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which causes AIDS and ARC in some laboratory studies but may increase virus replication in other laboratory studies Previous studies in humans showed no increase in virus cultures and some decrease in measurements of virus Extensive preclinical data show that TNF and IFN-G are more effective together than separately in laboratory and animal studies As single agents both TNF and IFN-G have modest effect against HIV Studies have demonstrated that TNF and IFN-G in combination can not only inhibit HIV infection of previously uninfected cells but also can selectively induce the destruction of acutely infected target cells
Patients with ARC who are positive for HIV antibody are randomized to receive one of three treatment arms 1 TNF alone by intramuscular injection IM 2 IFN-G alone by IM 3 TNF plus IFN-G Patients receive IM injections 3 times weekly for 4 months 16 weeks Repeated physical examinations and laboratory tests are used to monitor patients safety Serial HIV cultures and core antigen assays are employed to obtain evidence of antiviral activity and serial T cell and skin tests are used to measure immunologic effect
Patients with ARC who are positive for HIV antibody are randomized to receive one of three treatment arms 1 TNF alone by intramuscular injection IM 2 IFN-G alone by IM 3 TNF plus IFN-G Patients receive IM injections 3 times weekly for 4 months 16 weeks Repeated physical examinations and laboratory tests are used to monitor patients safety Serial HIV cultures and core antigen assays are employed to obtain evidence of antiviral activity and serial T cell and skin tests are used to measure immunologic effect
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 |
|---|---|---|---|
| 11001 | REGISTRY | DAIDS ES Registry Number | None |