Efficacy of the treatment with hydroxychloroquine in non responders HIV-infected HAART-treated patients - ND

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10008922; HIV infection (immunological nonresponders).

• Registration Number: EUCTR2009-012499-28-IT
• Lead Sponsor: AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

18 years of age or older patients, HIV positive with CD4 nadir pre-HAART<100cell/mm3, that meet the definition of INR, with an absolute T CD4+ count less than 200cells/mm3 and an increase in T CD4+ count less than 5% in the previous 6 months despite an effective antiretroviral therapy with NNRTI or bPI +2 NRTI.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Chronic liver disease, cardiopathy, retinopathy, known hypersensitivity to chloroquine and hydroxychloroquine, G6PDH deficit and pregnant and/or nursing women.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy oh hydroxychloroquine in increasing CD4 Tcells (50% campared to baseline) in a cohort of HIV-infected patients immunological non responders to HAART therapy.;Secondary Objective: To determine tolerability and safety of hydroxychloroquine treatment in the HIV-infected HAART-treated subjects enrolled in the study and efficacy of hydroxychloroquine in reducing T CD4+ cell apoptosis and T cell activation.;Primary end point(s): Absolute CD4 Tcells increase (>50% increase compared to baseline).