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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003685-33-IT
Enrollment
Unknown
Registered
2006-12-06
Start date
2006-09-27
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of HIV-1 infection in INRs patients compared to classical HAART. MedDRA version: 8.1 Level: LLT Classification code 10003581 Term: Asymptomatic HIV infection

Interventions

Trade Name: PROLEUKIN*EV 1FL 18MUI 5ML Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Aldesleukin CAS Number: 110942-02-4 Concentration unit: IU internationa

Sponsors

AZIENDA OSPEDALIERA L. SACCO A.O. DI RILIEVO NAZIONALE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026