ILIADEPhase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Anti-Retroviral TX in HIV Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm(3) Who Have Received Anti-Retroviral TX

Date de début de l'étude : 1 octobre 2003

* INCLUSION CRITERIA: Age greater than or equal to 18 years. HIV-1 infection confirmed by ELISA and Western Blot before screening. Category A or B HIV-1 infection. Antiretroviral treatment: * started at least 12 months prior to screening visit; * stable and continuous for at least 12 weeks prior to screening visit; * modified no more than once for virologic failure. IL-2 naive CD-4(+) T-lymphocyte count greater than or equal to 500 cells/mm(3) in the twelve weeks prior to screening (historical) and at screening. Nadir CD4(+) T-lymphocyte count greater than or equal to 200 cells/mm(3) prior to screening visit (that is, no measurement whose values may be less than 200/mm(3) since diagnosis of the HIV infection. Plasma HIV RNA less than 50 copies/ml in the 12 weeks preceding screening (historical, less than limit of detection if different method and/or cut off used) and at screening. For women of child-bearing age: use of effective contraception (hormonal such as birth control pill or injections, intrauterine device, surgical sterilization and/or mechanical barrier methods such as diaphragm or condoms); for all participants agreement to fully comply with prevention of transmission recommendations during periods of viremia if sexually active (latex condoms with or without additional barrier methods). Desire to interrupt antiretroviral therapy. Ability to sign informed consent (no later than W-2). EXCLUSION CRITERIA: Previous treatment with IL-2. Combined treatment with interferon, other interleukins, anti-HIV vaccines, systemic (not topical or inhaled) corticosteroids and hydroxyurea within the previous 12 weeks. Diagnosis of AIDS. Acute infection in the 14 days preceding inclusion. Pregnant, lactating woman desiring conception or not using contraception. Hemoglobin less than 10 g/dl; neutrophils less than 1,000/mm(3); platelets less than 50,000/mm(3); creatinine greater than 1.5 times the upper limit of normal (N); bilirubin greater than 3N; AST or ALT greater than 3 N. Progressive disease of malignant, psychiatric, cardiac, pulmonary, thyroid, renal or neurological (peripheral or central) origin or severe disorders of hemostasis. Severe uncontrolled hypertension. Previous or progressive pathology contraindicating the administration of IL-2. History of extensive psoriasis, Crohn's disease or auto-immune disease involving severe complications. HTLV-1 infection (ELISA positive). Hepatitis B virus co-infection treated with lamivudine or tenofovir or adefovir. Since atazanavir use can be associated with higher bilirubin levels (mostly indirect) in the absence of clinical consequences, subjects on atazanavir with bilirubin up to 4.5 times N may be allowed to participate if the levels have been stable and after approval by the PI or the PI designated covering physician.