Bisphosphonate Therapy with Zoledronic acid or Tenofovir Switching to Improve Low Bone Mineral Density in HIV-Infected Adults

Fundació Clínic per a la Recerca Biomèdica0 个研究点目标入组 84 人开始时间: 2014年1月16日最近更新: 2018年4月30日

适应症

试验速览

暂无简介。

•1. provision of written, informed consent
•2. HIV infected adult ?18 years of age
•3. stable and well-tolerated ART including tenofovir for the preceding 6 months
•4. plasma HIV RNA <50 copies/ml for at least the preceding 3 months
•5. eGFR >60ml/min (patients at higher risk of zoledronic acid/tenofovir nephrotoxicity)
•6. spine or neck of femur T score ? -1.0 measured by DXA (i.e. osteopenia)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 84
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 84

•1. prior bisphosphonate therapy
•2. use of tenofovir for previously active chronic hepatitis B co-infection
•3. requiring therapy for low BMD (e.g. prior fragility fracture; other metabolic bone disease)
•4. other secondary causes of osteoporosis: hypogonadism (total testosterone/oestrogen 25% above upper normal limit); hypothyroidism (low T4 and elevated TSH); hyperparathyroidism (elevated parathyroid hormone); inhaled fluticasone in a patient receiving ritonavir; prednisolone ?7.5mg/d or equivalent
•5. contra-indications to zoledronic acid (known hypersensitivity to bisphosphonates, hypocalcaemia, prior or current uveitis, eGFR<35 mL/min)
•6. recent (within the last 2 months) or planned dental surgery (at investigators discretion)
•7. previous virological failure (defined above), genotypic resistance, intolerance or contraindication to proposed switch antiretroviral drug
•8. HLA-B*5701 positive (abacavir contra-indicated) or prior ischaemic cardiovascular disease if planning to switch from tenofovir to abacavir
•9. concurrent use of any nephrotoxic drug
•10. breast-feeding or pregnancy

发起方

Fundació Clínic per a la Recerca Biomèdica