Exploratory study on inflammatory immune response related to endothelial dysfunction in HIV-infected na?ve patients treated with abacavir compared to tenofovir-based regimens. - ABRACADABRA

• Conditions: HIV INFECTION; MedDRA version: 9.1Level: PTClassification code 10020161

• Registration Number: EUCTR2009-011662-28-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SAN GERARDO DI MONZA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-19
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

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

Inclusion Criteria

- Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation - HIV-1-infected males or females >18 years of age - Positive serology for HIV (ELISA) confirmed by Western Blot - CD4 + cell count between 250-350 cells/L - HIV-RNA < 100.000 cp/ml - BMI <30 - No previous antiretroviral treatment - Negative pregnancy test at least 14 days before the beginning of treatment, women of childbearing potential must be using a highly effective method of contraception to avoid pregnancy throughout the study - Study drugs susceptibility based on HIV-1 genotypic resistance test
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

- Presence of HLA-B 5701 - Current smoker - Presence of diabetes - Presence of active inflammatory requiring anti-inflammatory therapy - Presence of opportunistic infections - Actual or previous cardiovascular diseases - Prior history of bone diseases - Actual or previous autoimmune disease - Previous documented altered expression of endothelial molecules and activation markers on CD4+ lymphocytes - Adequate renal function defined as a calculated creatinine clearance (CLCr) > 50 ml/min according to the MDRD formula The estimate was calculated using the Modification of Diet in Renal Diseases (MDRD) formula: eGFR (MDRD) = 186 x serum creatinine -1.154 x age -0.203 x 0.742 (if female) x 1.21 (if black) - Framinghan score > 10% (age, sex, systolic blood pressure, total cholesterol, HDL cholesterol, smoking status) www.chip.dk/tools.aspx - Presence of family history of cardiovascular disease Presence of thyroid disfunctions - Known intolerance or allergies to the investigational drugs treatments - Use of immunomodulant substances, growth factors, cytokines (e.g. interferon, cyclosporine, hydrohyurea, interleukin 2) or vaccines within 3 months - Use of lipid-lowering therapy is allowed if stable ≥ 12 weeks before and throughout study - Have systemic treatment with corticosteroid (e.g. chronic treatment with prednisone) or hormone therapy or chronic treatment with high dose non steroidal anti-inflammatory drugs (e.g. ibuprofene) within 3 months prior to study enter or are expected to receive these during the study - Ongoing therapy with nephrotoxic drugs (e.g. aminoglycosides, amphotericine B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus) or in 3 months prior to baseline or are expected to receive these during the study - Patients who are receiving systemic treatment for malignant disease - Pregnant or breast-feeding patients - Any current known clinical or symptomatic laboratory parameter Grade 4. Asymptomatic laboratory parameter will be permitted at the discretion of the investigator if deemed clinically appropriate (excluding adverse events and laboratory parameters mentioned in the exclusion/inclusion criteria) - Karnofsky index < 50 - Use of medications during the course of the study which are known to alter serum lipid levels, including growth hormone, anabolic steroids, megestrol, thalidomide, pentoxyfylline, systemic ketoconzole, cyclosporine or prolonged pharmacologic doses of glucocorticoids or testosterone preparations. Subjects who require hormone replacement therapy for endocrine conditions (e.g., testosterone, estrogen, progesterone, hydrocortisone, thyroid hormone) are allowed to participate, as long as they are receiving a physiologic replacement dose.

Study & Design

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