Interleukin-2 With and Without Antiretroviral Therapy to Treat HIV-1 Infection (STALWART)
This study will determine the safety and side effects of interleukin-2 (IL-2) taken with or without anti-HIV drugs and will see if IL-2 with or without anti-HIV drugs causes an increase in CD4 cells or a change in HIV viral load compared with no therapy at all. IL-2 is a protein that is produced naturally in the body and helps boost production of infection-fighting CD4 cells.
HIV-infected patients 18 years of age and older who have not previously taken IL-2 or taken any anti-HIV drug within 1 year of entering this study may be eligible for the study. Candidates are screened with a physical examination and blood tests during at least two screening clinic visits.
Participants are assigned by chance to one of the following three treatment groups:
- Standard of care treatment: This group does not receive IL-2 or anti-HIV drugs.
- IL-2 alone: This group receives three treatment cycles of IL-2. A cycle consists of an injection of IL-2 under the skin twice a day for 5 days in a row, followed by 7 weeks of no IL-2. After three cycles, patients may continue additional cycles for up to 2 years if the therapy is believed to be helpful. Patients are taught how to self-administer the IL-2.
- IL-2 plus anti-HIV drugs around IL-2 cycles only: This group receives three cycles of IL-2 as outlines above, but also receives 10 days of anti-HIV drugs around the IL-2 cycles (3 days before, 5 days during, and 2 days after IL-2 cycles).
Patients in the first two groups may begin anti-HIV therapy at any time they or their doctors believe it would be in their best interest to do so, and patients in the third group may begin continuous anti-HIV therapy or, conversely, stop all anti-HIV drugs, at any time it is believed to be in their best interest to do so.
All patients are followed in the clinic at least once a month for 8 months and then at least every 4 months for up to 2 years. The follow-up includes blood tests and possibly a visit with a doctor or nurse. Patients who develop side effects may need to be seen more frequently and may require additional blood and urine tests. Patients receiving IL-2 are seen for a clinical examination or blood tests, or both, to ensure that they are well before receiving each cycle. They are also seen on the last day of the dosing cycle and once again about one month after each cycle. They may need to be seen more often if they have a history of serious side effects during prior IL-2 treatments or if they develop serious side effects. Women who can become pregnant have a pregnancy test before starting each IL-2 cycle.
Some of the blood drawn for this study is used for genetic tests, and some blood is collected and stored for future studies.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 (rIL-2, Aldesleukin) With and Without Concomitant Antiretroviral Therapy in Participants w/HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm(3)|
- Mean changae in CD4+ T lymphocyte count from baseline to Week 32 in the three study groups. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||June 2011|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
No Intervention: No IL-2
Participants will receive no aldesleukin or HAART.
Experimental: IL-2 without ART
Participants 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.
Experimental: IL-2 with pericycle HAART
Participants 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; in addition, this group 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).
The purpose of this study is to compare the effects of subcutaneous (SC) recombinant interleukin-2 (rIL-2) administered with and without concomitant peri-cycle highly active antiretroviral therapy (HAART) to no therapy on CD4+ T lymphocyte count in patients with HIV-1 infection and CD4+ T lymphocyte count greater than or equal to 300 cells/mm(3).
|United States, Maryland|
|National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi|
|Bethesda, Maryland, United States, 20892|