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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly
Lamivudine 300 mg once dailly
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48
Mean change in BMD (g/cm²) at lumbar spine (L1-L4) and left hip measured by dual-energy X-ray absorptiometry (DXA) in human immunodeficiency virus-infected adults with hip or spine T-score between \< -1.0 and \>-2.5
Time frame: Baseline to Week 48
Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)
Time frame: 48 weeks
Proportion of Patients With Adverse Effects
Time frame: 48 weeks
Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen
Time frame: 48 weeks
Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase
Time frame: 48 weeks
Renald Disfunction Parameter: Estimated Glomerular Filtration Rate
Time frame: 48 weeks
Renald Disfunction Parameter: Phosphorus in Blood Sample
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples
Time frame: 48 weeks
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