Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 126
- 试验地点
- 5
- 主要终点
- Body weight
研究概览
简要总结
Randomized controlled parallel open-label study in persons living with HIV. The aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.
详细描述
Randomized controlled parallel open-label study in persons living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.
Participants (n=126) are randomized to continue 3 drug-regimen dolutegravir/tenofovir disoproxil/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention 1) or to three-drug regimen with doravirine/tenofovir disoproxil/lamivudine. 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 virus persistent viral suppression, changes in body composition and metabolism, changes in bone metabolisme and renal function, changes in liver elasticity and fat infiltration.
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
- •Individuals ≥ 18 years old with diagnosed HIV and at least 6 months of ongoing treatment with dolutegravir/ doravirin/lamivudine will be included. Patients must have a plasma viral load (HIV-RNA) < 50 copies/ml at inclusion. For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
排除标准
- •Patients will be excluded in case of pre-existing viral resistance mutations to lamivudine, dolutegravir, tenofovir or doravirine the presence of hepatitis B antigen (HBsAg) or HBV DNA, cancer within past 5 years, pregnancy or breastfeeding. Any case of diabetes, cardiovascular disease or other chronic illness must be considered stable as assessed by the treating physician.
研究组 & 干预措施
doravirine/tenofovir disproxil/lamivudine
100 mg doravirin, 245 mg tenofovirdisoproxil and 300 mg lamivudine once daily for 48 weeks.
干预措施: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] (Drug)
dolutegravir/lamivudine
dolutegravir 50 mg/lamivudine 300 mg once daily for 48 weeks
干预措施: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] (Drug)
结局指标
主要结局
Body weight
时间窗: 48 Weeks
Primary outcome is a change in body weight of more than 2 kg from
次要结局
- Virological control(48 weeks)
- Diabetic profile(48 weeks)
- Cholesterol profile(48 weeks)
- Fat distribution(48 weeks)
- Hepatic elasticity(48 weeks)
- Hepatic fat infiltration(48 weeks)
- Body composition/perfiferal and central fat distribution(48 weeks)
- Estimated Glomerular Filtration Rate (eGFR) (creatinine)(48 weeks)
- Self-rated health(48 weeks)
- Insulin resistance(48 weeks)
- eGFR (cystatin)(48 weeks)
- Urea(48 weeks)
- Urine RBP/creatinine ratio(48 weeks)
- Urine Beta-2-Microglobulin(B2M)/creatinine ratio(48 weeks)
- Urine albumin/creatinine ratio(48 weeks)
- Bone-specific alkaline phosphate(48 weeks)
- Procollagen type 1 N-pro-peptide(48 weeks)
- Type 1 collagen cross-linked C-telopeptide(48 weeks)
- Osteocalcin(48 weeks)
- Urine protein/creatinine ratio(48 weeks)
- Urine phosphate(48 weeks)
- Bone mass density (BMD)(48 weeks)
- Fasting ionized calcium(48 weeks)
- 25(OH)vitamin D vitamin D 25(OH)vitamin D(48 weeks)
- Parathyroid hormone (PTH) vitamin D 25(OH)vitamin D(48 weeks)
- Inflammation(48 weeks)
研究者
Thomas Benfield
MD, professor, dr.med.
Hvidovre University Hospital