Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000820
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
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:
PRIMARY To examine the effect of aldesleukin IL-2 on viral activity in the blood To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone
SECONDARY To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines
The profound immune impairment that results from HIV-1 infection is due at least in part to the loss of CD4 T cells and the cytokines these cells secrete especially IL-2 and interferon-gamma Antiretroviral agents do not directly address the problem of immune impairment Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections Also since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations IL-2 may provide an adjuvant effect on vaccine responses
SECONDARY To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines
The profound immune impairment that results from HIV-1 infection is due at least in part to the loss of CD4 T cells and the cytokines these cells secrete especially IL-2 and interferon-gamma Antiretroviral agents do not directly address the problem of immune impairment Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections Also since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations IL-2 may provide an adjuvant effect on vaccine responses
Detailed Description:
The profound immune impairment that results from HIV-1 infection is due at least in part to the loss of CD4 T cells and the cytokines these cells secrete especially IL-2 and interferon-gamma Antiretroviral agents do not directly address the problem of immune impairment Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections Also since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations IL-2 may provide an adjuvant effect on vaccine responses
Patients are randomized initially to receive their own antiretroviral therapy alone or in combination with IL-2 for 24 weeks after which each group is crossed over to the other treatment assignment ie IL-2 is either added or deleted from the regimen for an additional 24 weeks Patients who are vaccine eligible receive influenza tetanus and diphtheria toxoid and meningococcal polysaccharide vaccines at week 4 and those who have not received pneumococcal vaccine prior to study entry will receive it at week 8
Patients are randomized initially to receive their own antiretroviral therapy alone or in combination with IL-2 for 24 weeks after which each group is crossed over to the other treatment assignment ie IL-2 is either added or deleted from the regimen for an additional 24 weeks Patients who are vaccine eligible receive influenza tetanus and diphtheria toxoid and meningococcal polysaccharide vaccines at week 4 and those who have not received pneumococcal vaccine prior to study entry will receive it at week 8
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 |
|---|---|---|---|
| 11225 | REGISTRY | DAIDS ES Registry ID | None |