A Randomized, open label, international study of subcutaneous recombinant interleukin-2 with and without concomitant antiretroviral therapy in patient with HIV-1 infectious and CD4+ cell count >300/mm3 - STALWART

• Conditions: HIV-1 patients with CD4 > 300; MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2005-001490-95-IT
• Lead Sponsor: ational Institute of Allergy and Infectious Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-12
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- HIV positive - > age 18 - CD4 > 300/mmc - AST e ALT < 5X the upper limit of normal - bilirubinemia < 2x the normal ranges - Creatininemia<2 mg/dl - Granulocyte count >1000/mmc - Hemoglobin>10 g/dl. - No use ofvany ART since 1 year - Absence of autoimmune, cardiovascolar and neurologic diseases that can limited the use of IL-2
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-use of any immunomodulants - age< 18 -Any prior use of IL-2- presence of neoplasies except sarcoma Kaposi mucocutaneous - History of any AIDS-defining events- use of corticosteroids, chemotherapy or experimental cytotoxic drug within 45 days prior to randomization -Any CNS abnormality that requires ongoing treatment with antiseizure medication -Pregnancy or breastfeeding -Psichiatric diseases or illicit substance use/abuse that would make the partecipant not candidate for the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effects of subcutaneous recombinant interleukin-2 administered with or without concomitant pericycle of antiretroviral therapy.;Secondary Objective: Evaluate the difference among the three arms after week 32 in term of: incidence of grade 3 and 4, number of ART modifications, value of viremia changes from baseline;Primary end point(s): Change in CD4 count from baseline to week 32 in the three study groups.