Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110812
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2005-05-13
Brief Title:
Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
STALWART A Randomized Open-Label International Study of Subcutaneous Recombinant Interleukin-2 With and Without Concomitant Antiretroviral Therapy in Patients With HIV-1 Infection and CD4 Cell Counts of 300 Cellsmm3 or More
Status:
COMPLETED
Status Verified Date:
2014-04
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:
STALWART
Brief Summary:
The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 also known as rIL-2 or aldesleukin given with or without anti-HIV drugs in HIV infected patients The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy
Study hypothesis Intermittent aldesleukin when given without antiretroviral therapy to patients with early HIV infection will produce no change in HIV viral load and increases in CD4 T lymphocyte counts comparable to aldesleukin administered with antiretrovirals
Study hypothesis Intermittent aldesleukin when given without antiretroviral therapy to patients with early HIV infection will produce no change in HIV viral load and increases in CD4 T lymphocyte counts comparable to aldesleukin administered with antiretrovirals
Detailed Description:
Highly active antiretroviral therapy HAART has dramatically improved prognosis and lowered morbidity and mortality rates for HIV infected patients However significant drug toxicities difficulties with patient compliance to HAART regimens and development of drug resistance highlight the need for less toxic immune-based strategies Aldesleukin is a synthetic protein that can increase CD4 counts it is currently approved by the Food and Drug Administration FDA for use in patients with metastatic melanoma and renal cell carcinoma Previous studies of aldesleukin in HIV infected patients indicated that increased CD4 counts can persist for years after aldesleukin administration and aldesleukin given with HAART may also lead to significant lowering of viral load This study will examine the immunologic effects of intermittent cycles of aldesleukin administered with and without HAART as compared to no therapy in HIV infected patients
This study will last approximately 31 months Participants will be randomly assigned to one of three groups at study entry Group A will receive no aldesleukin or HAART Group B will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles then as needed to maintain CD4 counts at or above a goal level Group C will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles then as needed to maintain CD4 counts at or above a goal level Group C participants will also take HAART for 3 days prior to the start of each aldesleukin cycle throughout the 5-day aldesleukin cycle and for 2 days after the end of each aldesleukin cycle for a maximum of 10 days with each aldesleukin cycle HAART will not be provided by the study Some Group B and C participants may take part in additional cycles of aldesleukin if they meet certain study criteria
All participants in this study will have at least 8 study visits these visits will occur at study entry and Weeks 4 8 12 16 20 24 and 32 Blood collection will occur at all visits and will include tests for CD4 count and viral load Groups B and C will have additional blood collection within 4 days prior to the start of each aldesleukin cycle On the last day of each aldesleukin cycle Groups B and C will be assessed for toxicities adverse events and adherence to the aldesleukin daily injections they will also have another blood collection Group C participants will have an additional blood collection for HIV genotyping after they have completed their third aldesleukin cycle Extended follow-up visits will occur approximately every 4 months for an additional two years Blood collection will occur at these visits and will include tests for CD4 count viral load and other laboratory tests
This study will last approximately 31 months Participants will be randomly assigned to one of three groups at study entry Group A will receive no aldesleukin or HAART Group B will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles then as needed to maintain CD4 counts at or above a goal level Group C will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles then as needed to maintain CD4 counts at or above a goal level Group C participants will also take HAART for 3 days prior to the start of each aldesleukin cycle throughout the 5-day aldesleukin cycle and for 2 days after the end of each aldesleukin cycle for a maximum of 10 days with each aldesleukin cycle HAART will not be provided by the study Some Group B and C participants may take part in additional cycles of aldesleukin if they meet certain study criteria
All participants in this study will have at least 8 study visits these visits will occur at study entry and Weeks 4 8 12 16 20 24 and 32 Blood collection will occur at all visits and will include tests for CD4 count and viral load Groups B and C will have additional blood collection within 4 days prior to the start of each aldesleukin cycle On the last day of each aldesleukin cycle Groups B and C will be assessed for toxicities adverse events and adherence to the aldesleukin daily injections they will also have another blood collection Group C participants will have an additional blood collection for HIV genotyping after they have completed their third aldesleukin cycle Extended follow-up visits will occur approximately every 4 months for an additional two years Blood collection will occur at these visits and will include tests for CD4 count viral load and other laboratory tests
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 |
|---|---|---|---|
| 10053 | REGISTRY | DAIDS ES Registry Number | None |