HIV infection, osteopenia
Conditions
Interventions
Trade Name: Isentress
Pharmaceutical Form: Tablet
Sponsors
Unit of Infectious Diseases, Department of Medical Scieces, University of Torino c/o ASLTO2, Amedeo di Savoia Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 (25ng/mL, FSH>25ng/mL and E2=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate. • Documented resistance to Raltegravir or/and Atazanavir. • Patient with significant hypersensitivity or other contraindication to any of the components of the study drugs. • Patient has a current (active) diagnosis of acute hepatitis due to any cause • Patient with coinfection HIV/HBV • Liver cirrhosis • Osteoporosis (t-score less than 2.5). • Secondary endocrinological cause of low BMD • Chronic steroid intake; • Chronic kidney disease (estimated glomerular filtration rate below 60 ml/min*24h); • Concomitant use of bisphosphonate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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); ;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. ;Timepoint(s) of evaluation of this end point: Baseline, week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactClinica Universitaria di Malattie I
Unit of Infectious Diseases, Department of Medical Scieces, University of Torino c/o ASLTO2, Amedeo di Savoia Hospital
Outcome results
None listed