Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People
Condition: HIV Infections
MeSH terms: Infections
Intervention: IL-2
Intervention description: 7.5 MIU injected intramuscularly; one arm uses Proleukin together with HAART of choice (protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors)
Intervention MeSH terms: Aldesleukin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 267.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Naive; IL-2; rIL-2

Summary:

      The purpose of this study is to determine the effect of short cycles of recombinant
      interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in
      HIV infected patients. The effects will be compared with a study group that receives no IL-2
      or antiretroviral therapy.

      Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to
      patients with early HIV infection, will produce no change in HIV viral load and increases in
      CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected

          -  CD4 count of 300 cells/mm3 or more

          -  Access to a HAART regimen consisting of 1 or more protease inhibitors (PIs) and 2 or
             more nucleoside or nucleotide reverse transcriptase inhibitors

        Exclusion Criteria:

          -  Prior use of aldesleukin

          -  Approved or experimental antiretroviral drug (including hydroxyurea) within 1 year
             prior to study entry

          -  Evidence of virologic failure on a PI- or nonnucleoside-based HAART regimen

          -  Any current indication for continuous HAART, in the opinion of the investigator

          -  Any contraindication to HAART, in the opinion of the investigator

          -  Systemic corticosteroids, chemotherapy, or experimental cytotoxic drugs within 45 days
             of randomization

          -  Approved or experimental agents with clinically significant immunomodulatory effects
             within 8 weeks prior to randomization

          -  History of any AIDS-defining illness or certain other diseases. More information on
             this criterion can be found in the protocol.

          -  Concurrent cancer requiring cytotoxic therapy

          -  Any central nervous system (CNS) abnormality requiring ongoing treatment with
             antiseizure medication

          -  Current or prior autoimmune or inflammatory diseases, including inflammatory bowel
             disease, psoriasis, optic neuritis, or any other autoimmune or inflammatory diseases
             with potentially life-threatening complications

          -  Significant heart, lung, kidney, liver, gastrointestinal, CNS, or psychiatric disease
             OR illicit substance use or abuse that, in the opinion of the investigator, would
             interfere with the study

          -  Pregnancy or breastfeeding