Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Changes in body weight of ≥2 kg
研究概览
简要总结
Randomized controlled parallel open-label study in people living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.
Participants (n=95) are randomized to continue 3 drug-regimen dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention). Follow-up is 48 weeks. Data is collected at baseline and week 48. Primary outcome is changes in weight from baseline of more than 2 kg. Secondary outcomes are changes in cardiac risk, composition and calcification of the heart tissue, and changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is applied to focus on the cardiac adverse effects of abacavir.
详细描述
In the MRI sub study 40 patients from the main study (20 from each group) are included. A cardiac MRI are performed at baseline and week 48 to evaluate cardiac effects of abacavir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •≥ 18 years old
- •Diagnosed HIV
- •At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine
- •Plasma viral load (HIV-RNA) < 50 copies/ml at inclusion
- •For women of childbearing potential:
- •Negative pregnancy test
- •Willingness to use contraceptive (consistent with local regulations) during study period
排除标准
- •Pre-existing viral resistance mutations to lamivudine or to dolutegravir
- •Presence of hepatitis B antigen (HBsAg) or Hepatitis B virus DNA (HBV DNA)
- •Cancer within past 5 years
- •Diabetes, cardiovascular disease or other chronic illness considered stable as assessed by the treating physician
- •For women of childbearing potential:
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
dolutegravir/lamivudine
50 mg dolutegravir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
干预措施: Dolutegravir / Lamivudine Oral Tablet (Drug)
结局指标
主要结局
Changes in body weight of ≥2 kg
时间窗: 48 weeks
Fasting body weight
次要结局
- Virological control(48 weeks)
- Changes in cardiac risk(48 weeks)
- Changes in carotid artery intima-media thickness (cIMT)(48 weeks)
- Changes in fat distribution in trunk, limb and extremities(48 weeks)
- Changes in d-dimer(48 weeks)
- Changes in blood Hemoglobin(48 weeks)
- Changes in plasma creatinine(48 weeks)
- Changes in plasma potassium(48 weeks)
- Changes in bloodpressure(48 weeks)
- Changes in liver fat infiltration(48 weeks)
- Changes in interleukins(48 weeks)
- Changes in soluble P-selectin(48 weeks)
- Changes in soluble glycoprotein VI(48 weeks)
- Changes in fibrinogen(48 weeks)
- Changes in plasma urea(48 weeks)
- Changes in plasma sodium(48 weeks)
- Changes in plasma bilirubin(48 weeks)
- Changes in plasma alanine(48 weeks)
- Cardiovascular risk(48 weeks)
- Changes in self-rated health(48 weeks)
- Change in metabolism(48 weeks)
- Changes in liver stiffness(48 weeks)
- Changes in endothelial function(48 weeks)
- Changes in coagulation(48 weeks)
- Changes in Coronary artery calcium score (CACS)(48 weeks)
- Changes in cardiac blood markers(48 weeks)
- Changes in fat distribution VAT/SAT(48 weeks)
- Changes in inflammation(48 weeks)
- Changes in blood platelets(48 weeks)
- Changes in plasma aminotransferase(48 weeks)
- Cardiac biomarkers(48 weeks)
研究者
Thomas Benfield
MD, DMsc, professor,
Hvidovre University Hospital