NIAID HIV and Emerging Infectious Diseases Program

STALWART Study

Study name

A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 (rIL-2, Aldesleukin) With and Without Concomitant Antiretroviral Therapy in Participants with HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm(3)

Study number

05-I-0123

Goal of Study

The NIH is conducting a research study to evaluate the safety and side effects of IL-2 taken with or without anti-HIV drugs, and we will see if IL-2 causes an increase in CD4 cells, and if IL-2 has an effect on viral load.

Study Regimen

You will have an equal, random chance of being placed in one of three groups. All volunteers will be compensated.

Standard of care treatment: You will not receive IL-2 or anti-HIV drugs. If you need to begin taking anti-HIV drugs while on the study, the study will not provide those medications.

IL-2 alone group: IL-2 injections, below the skin, twice a day for 5 days in a row (this is called a “cycle” of IL-2). After 7 weeks of no IL-2, there will be another cycle; this will be repeated a third time. Participants may continue to cycle every 8 weeks if it is determined that the IL-2 is helping them.

IL-2 plus anti-HIV medications: This group will get three IL-2 cycles, as outlined above, but will also take anti-HIV drugs 3 days before, 5 days during, and 2 days after each cycle. These drugs will be provided by the study; however, if it were determined that it would be in an individual’s best interest to remain on the drugs continuously, the study will not provide anti-HIV drugs for continuous treatment.

Eligibility Criteria

• You are age 18 or older with documented HIV infection
• You have not previously taken IL-2
• You have not taken anti-HIV drugs for at least one year
• You do not need to be on anti-HIV drugs continuously
• You and your doctor agree that you should take anti-HIV drugs, but not continuously
• You were not previously on anti-HIV drugs that included a protease inhibitor that did not suppress the virus
• You have not taken corticosteroids (like prednisone) within 45 days of study randomization
• You have not taken agents that affect your immune system within 8 weeks of randomization
• You do not have a history of inflammatory disease that may be worsened by IL-2

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