Simplification from Tenofovir plus Lamivudine or Emtricitabine plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir plus Lamivudine in Virologically-Suppressed-HIV-Infected Adults with Osteopenia: a pilot study - Osteosimply014

Fundació Clínic per a la Recerca Biomèdica0 个研究点目标入组 45 人开始时间: 2014年11月19日最近更新: 2018年1月8日

适应症

试验速览

暂无简介。

•- Adult (18 years old or more) HIV-1-infected subjects.
•- Hip or spine T-scores between <-1.0 measured and >-2.5 mesured by dual-energy X-ray absorptiometry (DXA) (in the previous 24 weeks).
•- On stable cART based on TDF+3TC or FTC+r/PI for at least 24 weeks.
•- Having plasma HIV-1 RNA <50 copies/mL for at least the previous 24 weeks, including at least two samples.
•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 45
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Pregnancy, breast-feeding status or plans for pregnancy in the short term.
•- Primary genotypic resistance mutations and/or previous virological failures to ATV or 3TC/FTC.
•- 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), untreated.
•- 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)
•- BMI lower than 19.

发起方

Fundació Clínic per a la Recerca Biomèdica