Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000647
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
1999-11-02
Brief Title:
An Open Trial Combining Zidovudine Interferon-alfa and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open Trial Combining Zidovudine Interferon-alfa and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
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 restore immunologic function and virus-free state in HIV-infected patients Based on previous studies showing temporary improvement in immune function in HIV-infected patients using peripheral lymphocyte transfers and bone marrow transplantation and based on studies documenting the antiretroviral effects of zidovudine AZT and interferon-alfa IFN-A as well as the preliminary test tube and patient studies suggesting anti-HIV effects of recombinant CD4-IgG we propose to treat HIV-infected patients using combination antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from previously immunized donors in an attempt to restore immunologic function and a virus-free state
Detailed Description:
Based on previous studies showing temporary improvement in immune function in HIV-infected patients using peripheral lymphocyte transfers and bone marrow transplantation and based on studies documenting the antiretroviral effects of zidovudine AZT and interferon-alfa IFN-A as well as the preliminary test tube and patient studies suggesting anti-HIV effects of recombinant CD4-IgG we propose to treat HIV-infected patients using combination antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from previously immunized donors in an attempt to restore immunologic function and a virus-free state
Three patients are treated with stable doses of AZT IFN-A and CD4-IgG for 12 weeks followed by six peripheral lymphocyte infusions and transplantation of bone marrow from their respective identical twins Following bone marrow transplantation patients continue to receive the three drugs Additional periods of lymphocyte apheresis and transfer may be offered to each donorrecipient pair
Three patients are treated with stable doses of AZT IFN-A and CD4-IgG for 12 weeks followed by six peripheral lymphocyte infusions and transplantation of bone marrow from their respective identical twins Following bone marrow transplantation patients continue to receive the three drugs Additional periods of lymphocyte apheresis and transfer may be offered to each donorrecipient pair
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 |
|---|---|---|---|
| NIAID 90 CC-IRP011 | Registry Identifier | DAIDS ES Registry Number | None |
| 11723 | REGISTRY | None | None |
| 90 I-0076 | None | None | None |