Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia

Not Applicable

Brief Summary: A 48-week, open label, non comparative prospective trial in stable chronic human immunodeficiency virus-infected patients having achieved complete virological suppression for more than 24 weeks (human immunodeficiency virus-1 RNA \<50 c/ml) switching from an antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted protease inhibitor to boosted atazanavir and lamivudine Study visits will take place at screening, baseline, weeks 4, 12, 24, and 48.

Recruitment & Eligibility

Inclusion Criteria

Human immunodeficiency virus-1-infected subjects with age ≥18 years old
Hip or spine T-scores between < -1.0 and >-2.5 by dual-energy X-ray absorptiometry (in the previous 24 weeks)
Stable antiretroviral treatment based on tenofovir and lamivudine or emtricitabine and boosted protease inhibitor for at least 24 weeks.
Having plasma human immunodeficiency virus-1 RNA <50 copies/mL for at least the previous 24 weeks, including at least two samples.

Exclusion Criteria

Pregnancy, breast-feeding status or plans for pregnancy in the short term
Primary genotypic resistance mutations and/or previous virological failures to atazanavir or lamivudine/emtricitabine
Chronic hepatitis B infection
Patients with indication for therapy for the prevention of bone fractures
25-OH vitamin D deficiency (< 10ng/mL)
Hypogonadism (low total testosterone according to local reference range)
Hypothyroidism (low T4 and increased thyroid stimulating hormone levels according to local reference ranges)
Hyperparathyroidism (increased parathyroid hormone level with hypercalcaemia according to local reference ranges)
Having received oral corticosteroids or inhaled fluticasone (daily doses higher than 5 mg/d prednisone equivalent for 3 months or more)
Using anti-resorptive therapy (Calcium and vitamin D supplements are encouraged but not mandated)
Body mass index lower than 19

Arm && Interventions

Group	Intervention	Description
Experimental	Boosted atazanavir	All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.
Experimental	Lamivudine	All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.

Primary Outcome Measures

Name	Time	Method
Change in bone mineral density by dual-energy X-ray absorptiometry in human immunodeficiency virus-infected adults with hip or spine T-score between < -1.0 and >-2.5 by dual-energy X-ray absorptiometry	48 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients free of virologic failure (confirmed viral load≥ 50 copies/mL)	48 weeks
Bone turnover markers in blood: bone-specific alkaline phosphatase	48 weeks
Renald disfunction, tubule dysfunction, parameter: glucose in urine	48 weeks
Adverse effects	48 weeks
Bone turnover markers in blood: urinary N-terminal telopeptide of type-1 collagen	48 weeks
Renald disfunction, tubule dysfunction, parameter: beta-2 microglobulin in urine samples	48 weeks
Renald disfunction, tubule dysfunction, parameter: creatinin in urine samples	48 weeks
Renald disfunction, tubule dysfunction, parameter: phosphorus in urine samples	48 weeks
Renald disfunction parameter: phosphorus in blood sample	48 weeks
Renald disfunction, tubule dysfunction, parameter: protein in urine samples	48 weeks
Renald disfunction, tubule dysfunction, parameter: albumin in urine samples	48 weeks
Renald disfunction parameter: estimated glomerular filtration rate	48 weeks
Renald disfunction, tubule dysfunction, parameter: N-Acetyl-β-D Glucosaminidase in urine samples	48 weeks

Locations (1): Hospital Clínic i Provincial de Barcelona
🇪🇸
Barcelona, Spain

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