Study of viro-immunological dynamics and T-lymphocyte homeostasis in peripheral blood in the pathogenesisof HIV infection and in the response to antiretroviral therapy. - ND

• Conditions: Treatment of HIV-1 infection in INRs patients compared to classical HAART.; MedDRA version: 8.1Level: LLTClassification code 10003581Term: Asymptomatic HIV infection

• Registration Number: EUCTR2006-003685-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERA L. SACCO A.O. DI RILIEVO NAZIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Antiretroviral-treated HIV patients treated with 1 protease inhibitor or 1 non-nucleosidic inhibitor of inverse transcriptase 2 nucleosidic inhibitors of inverse transcriptase HAART for at least 12 months and with HIV-RNA 50 cp/ml in at least 3 consecutive determinations and CD4 constantly 200/ul immunological-non-responders INRs .
Are the trial subjects under 18? no
Number of subjects for this age range:
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

Allergy or intollerance towards the IMP; previous or current treatment with immunomodulatory drugs or growth factors or cytokines; systemic treatment with steroids within 4 weeks from the beginning of treatment; Karnofsky index 50.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the immunologic efficacy, considered as the increase in CD4 cell counts, in INRs patients who modify their current HAART and introduce an immunoadjuvant therapy with IL-2 and /or intensify their HAART introducing a fusion inhibitor FI .;Secondary Objective: Evaluate the modifications in plasma HIV-RNA in INRs patients who modify their current HAART and introduce an immunoadjuvant therapy with IL-2 and /or intensify their HAART introducing a fusion inhibitor FI . Evaluate the occurrence of drug-related side effects during the study protocol. Evaluate the occurrence of clinical events minor and major OIs during the study protocol. Evaluate the modification of immunologic and virologic parameters.;Primary end point(s): Number of subjects with lymphocyte T CD4 250 cell/ul after 3 month of HAART intensification with immunotherapy with IL-2 and after 6 and 12 months of follow-up.