• Mean change in CD4+ T lymphocyte count [ Time Frame: Through Week 32 ] [ Designated as safety issue: No ]
  

• Grade 3 and 4 events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  
• Therapy modification as defined by the protocol [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Plasma HIV RNA [ Time Frame: At Week 32 and Month 12 ] [ Designated as safety issue: No ]
  
• CD4 T lymphocyte count [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
  
• HIV-1 genotype changes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Fasting lipid profile and thyroid stimulating hormone and hepatic transaminase levels [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  

Highly active antiretroviral therapy (HAART) has dramatically improved prognosis and lowered morbidity and mortality rates for HIV infected patients. However, significant drug toxicities, difficulties with patient compliance to HAART regimens, and development of drug resistance highlight the need for less toxic, immune-based strategies. Aldesleukin is a synthetic protein that can increase CD4 counts; it is currently approved by the Food and Drug Administration (FDA) for use in patients with metastatic melanoma and renal cell carcinoma. Previous studies of aldesleukin in HIV infected patients indicated that increased CD4 counts can persist for years after aldesleukin administration, and aldesleukin given with HAART may also lead to significant lowering of viral load. This study will examine the immunologic effects of intermittent cycles of aldesleukin administered with and without HAART as compared to no therapy in HIV infected patients.

This study will last approximately 18 months. Participants will be randomly assigned to one of three groups at study entry. Group A will receive no aldesleukin or HAART. Group B 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. Group C 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; Group C participants 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). HAART will not be provided by the study. Some Group B and C participants may take part in additional cycles of aldesleukin if they meet certain study criteria.

All participants in this study will have at least 8 study visits; these visits will occur at study entry and Weeks 4, 8, 12, 16, 20, 24, and 32. Additional follow-up visits will occur every 4 months to the end of the study. Blood collection will occur at all visits and will include tests for CD4 count and viral load. Groups B and C will have additional blood collection within 4 days prior to the start of each aldesleukin cycle. On the last day of each aldesleukin cycle, Groups B and C will be assessed for toxicities, adverse events, and adherence to the aldesleukin daily injections; they will also have another blood collection. Group C participants will have an additional blood collection for HIV genotyping after they have completed their third aldesleukin cycle.