The purpose of this study is to find out if the immune systems of HIV-positive patients can
be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early
stages of HIV infection.
IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV
spreads throughout the body by invading CD4 cells, which are cells of the immune system that
fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can
help restore the CD4 cell count and the immune functions. This study will look at how the
HIV virus acts during the early stages of HIV infection, how the immune system responds to
HIV, and what impact early treatment with anti-HIV medications has on the course of HIV
At the time of initial HIV infection, CD4 cells are susceptible to infection, and the virus
infects many T cells during the first 4 to 6 weeks. Many of these infected cells
subsequently maintain the virus in a latent state. Immune reconstitution with daily low-dose
IL-2 therapy is intended to correct or improve the deficiency in CD4 cells, while
maintaining a high frequency of CD8+ HIV-specific CTL and increasing natural killer (NK)
cells. After a year of HAART plus IL-2, it may be possible to discontinue HAART while
maintaining IL-2 stimulatory therapy, and the immune reactivity repaired and stimulated by
IL-2 should be able to contain the virus and maintain latency.
Patients are randomized to add IL-2 to their current HAART regimen or simply to remain on
their current HAART regimen. IL-2 therapy is initiated at Month 3 of HAART. IL-2 is injected
subcutaneously daily for 9 months, in addition to HAART. After completion of this 1-year
treatment period, patients are evaluated for discontinuation of HAART. Patients with a viral
load below 50 copies/ml throughout HAART plus IL-2, a CD4 count of at least 500 cells/mm3,
and no onset of opportunistic infections may have HAART discontinued and IL-2 continued as
monotherapy for an additional 6 months. After completing 6 months of IL-2 monotherapy,
eligible patients may have IL-2 therapy discontinued.
Patients may be eligible for this study if they:
- Viral load of 5,000 copies/ml or less within 3 months.
- Completed at least 3 months of anti-HIV medications.
- Have a refrigerator to store the needles for IL-2 shots.
- Glucocorticoids or other drugs that affect the immune system such as INF-alpha,
G-CSF, or GM-CSF.