A Phase I, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Safety of Subcutaneous Single Dose Interleukin Subtype in HIV-1-Infected Subjects Who Are Receiving Antiretroviral Treatment

This study will assess the safety of a new experimental drug. The drug is one of the subtypes of the natural IL protein produced in the body. The drug is important in the function of the immune system (the system that helps your body fight infection). Animal studies have shown it can improve the function of the immune system including increases in T-cell counts.

In this study the drug will be given as a subcutaneous (under the skin) injection. The study drug is not approved by the Food and Drug Administration (FDA) and has never been given to HIV-infected persons. This study will test if it is safe to use the drug in people infected with HIV and will also look at the amount of the drug in your blood after you receive the injection. The safety of the study drug is currently being studied in persons with cancer in a separate study sponsored by the National Cancer Institute (NCI) using similar dose levels of the drug that are being used in study. In the future, new and important safety information from the NCI study will be shared with persons participating in this study. If this study shows that the drug is safe, additional studies will be done to see if it can improve the function or numbers of T-cells in HIV-infected persons.

• Men and women who are 18 or older
• HIV-1 infection
• Screen CD4+ cell count 100 cells/mm³ or higher
• HIV-1 RNA of 50,000 copies/mL or less