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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Experimental
All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.
干预措施: Boosted atazanavir (Drug)
Experimental
All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.
干预措施: Lamivudine (Drug)
结局指标
主要结局
Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48
时间窗: 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
次要结局
- Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples(48 weeks)
- Proportion of Patients With Adverse Effects(48 weeks)
- Renald Disfunction Parameter: Estimated Glomerular Filtration Rate(48 weeks)
- Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine(48 weeks)
- Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)(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, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples(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, Tubule Dysfunction, Parameter: Creatinin in Urine Samples(48 weeks)
- Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples(48 weeks)
研究者
Judit Pich
Clinical Research Manager
Hospital Clinic of Barcelona