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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Boosted atazanavir
* Drug: Lamivudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily. | Drug: Boosted atazanavir<br>* Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly<br>Drug: Lamivudine<br>* Lamivudine 300 mg once dailly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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