An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
Condition: HIV Infections
MeSH terms: Infections
Intervention: Recombinant interleukin-2 (rIL-2)
Intervention description: Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.
Intervention MeSH terms: Aldesleukin; Interleukin-2
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recombinant Proteins; Injections, Subcutaneous; HIV-1; Interleukin-2; Drug Therapy, Combination; CD4 Lymphocyte Count; Disease Progression; Follow-Up Studies; Anti-HIV Agents

Summary:

      The purpose of this study is to see if it is effective to give HIV positive patients
      recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed
      over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease
      progression.

      Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping
      viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the
      body of the virus, and the immune system is never completely restored in HIV positive
      patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to
      their anti-HIV therapy will help improve their immune systems and keep them healthier over a
      longer period of time. rIL-2 is a hormone naturally produced by the body during an immune
      response to a microbial infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV positive

          -  Have a CD4 cell count of 300 cells/mm3 or more within 45 days of study entry

          -  Are on combination anti-HIV therapy or are beginning anti-HIV therapy at the time of
             study entry

          -  Are at least 18 years old

        Exclusion Criteria:

          -  Have received IL-2 before

          -  Have cancer requiring chemotherapy

          -  Have evidence of active clinical disease within the past year for any AIDS-defining
             illness or certain other conditions such as herpes zoster or Chagas disease. (This
             study has been changed. Previously, patients were ineligible if they had a history of
             any AIDS-defining illness or certain other conditions.)

          -  Have used certain medications, such as corticosteroids or drugs affecting the immune
             system, in the 45 days before study entry

          -  Have a nervous system disorder requiring antiseizure medication

          -  Have an autoimmune or inflammatory disease such as inflammatory bowel disease (e.g.,
             Crohn's disease or ulcerative colitis), psoriasis, optic neuritis, or any
             autoimmune/inflammatory diseases with potentially life-threatening complications

          -  Are pregnant or breastfeeding