“Switching HIV-positive Women With Undetectable Viremia on Tenofovir/Emtricitabine plus Boosted Atazanavir to RALtegravir (400 mg twice-daily) plus Boosted ATazanavir (300/100 mg once-daily): A Pilot Randomized Clinical Trial Investigating 48-weeks Changes in Bone Mineral Density”

INTERVENTION: Trade Name: Isentress Pharmaceutical Form: Tablet CONDITION: HIV infection, osteopenia Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To assess the improvement in Bone Mineral Density and markers of bone turnover in women on TDF/FTC + ATV/r in a switch arm (RAL + ATV/r) vs. an unchanged arm (TDF/FTC + ATV/r). Primary end point(s): • To assess variations from baseline in DEXA bone mineral density (spine and femur) at 48 weeks in the two arms;; • To assess variations from baseline in CTX (C‐terminal telopeptide of type I collagen) and OC (Osteocalcin) at 24 and 48 weeks in the two arms.; Secondary Objective: Secondary Objectives:; • To assess the variation in glomerular filtration rate, urinary markers of tubular dysfunction (nondiabetic glucosuria, altered resorption of phosphorus, hyperaminoaciduria, b2‐microglobulinuria and abnormal uric acid excretion.) and urinary retinol binding protein in the two arms at 24 and 48 weeks; ; • To asses metabolic and hormonal profile changes at 48 weeks in the two arms (cholesterol, triglycerides, glucose fasting levels, insulin, PTH and 25‐OH‐vitamin D);; Timepoint(s) of evaluation of this end point: Baseline, week 48 SECONDARY OUTCOME: Secondary end point(s): Secondary Objectives: ; • To assess the variation in glomerular filtration rate, urinary markers of tubular dysfunction (nondiabetic glucosuria, altered resorption of phosphorus, hyperaminoaciduria, b2‐microglobulinuria and abnormal uric acid excretion.) and urinary retinol binding protein in the two arms at 24 and 48 weeks; ; • To asses metabolic and hormonal profile changes at 48 weeks in the two arms (cholesterol, triglycerides, glucose fasting levels, insulin, PTH and 25‐OH‐vitamin D); ; Timepoint(s) of evaluation of this end point: baseline, week 24 and week 48 INCLUSION CRITERIA: INCLUSION CRITERIA: • Adult HIV‐positive female patients; • osteopenia (t‐score from ‐1 to ‐2.5) • On antiretroviral treatment with tenofovir/emtricitabine and atazanavir/ritonavir (300/100 mg) for at least six months; • Plasma HIV RNA below 50 copies/ml since six months; • Premenopausal women: female patients at any phase of the reproductive period with regular menstrual cycles and normal FSH (< 25 ng/mL) That would probably esclude patients with ovarian or endocrinological dysfunctions. Pre and postmenopausal should be therefore well‐characterized. • Women in menopausal period (the menopause was defined as 12 months of amenorrhoea without any pathological or physiological cause and using the endocrinological definition of ovary insufficiency (LH>25ng/mL, FSH>25ng/mL and E2<30ng/mL). • Each premenopausal sexually active subject of child‐bearing potential must agree to use a medically accepted method of contraception while receiving p