Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients

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.

Inclusion Criteria

Patients may be eligible for this study if they:

- HIV-infected.

- 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.

Exclusion Criteria

- Glucocorticoids or other drugs that affect the immune system such as INF-alpha,
G-CSF, or GM-CSF.