HIV INFECTION MedDRA version: 9.1 Level: PT Classification code 10020161
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Abacavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical Form: Tablet
INN or Proposed INN: Ten
Sponsors
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate variation in endothelial adhesion molecules and leukocyte activation markers in HIV-positive na?ve patients treated with abacavir compared to tenofovir in combination with fixed NNRTI composed by efavirenz;Secondary Objective: 1. Evaluation of fasting metabolic parameters (e.g. LDL, HDL, non-HDL cholesterol, triglycerides and cholesterol ratio) at baseline, week 4, 12 and 24 2. Evaluation of endothelium function measured by flow-mediated dilation (FMD) of the radial artery and brachial artery diameter (BAD), aortic stiffness measure by aortic pulse-wave velocity (PWV) and endothelium structure measured by echodoppler evaluation of carotid intima-media thickness (IMT) from baseline at week 24 3.Evaluation of efficacy and safety by assessing adverse events, clinical laboratory tests, physical examinations and vital sing at every visit 4.Evaluation of change in the 10-year risk factor for coronary heart disease outcomes as measured by Framinghan formula;Primary end point(s): To evaluate changes from baseline in expression of endothelial adhesion molecules and activation markers on CD4+ lymphocytes (DRII, CD11A, CD62L, CD49D, CD44) and monocytes (CD36, TLR2, TLR4, CD80, CD86) after 24 weeks. | — |
Countries
Italy
Outcome results
None listed