Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
研究概览
简要总结
This is a open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The four arms are as follows:
Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF + MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)
The allocation will take place in two phases:
Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan
If losartan arm shows benefits we will proceed to the second phase:
Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.
Patients will be followed up during 12 months to determinate the proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.
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
- •Patients older than 18 years.
- •Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with undetectable viral load (VL <37 copies) for at least 48 weeks.
- •Nadir CD4 +> 250 cells/mm
- •Patients, properly informed, give their written consent to participate in the study.
排除标准
- •Criteria for patients with AIDS.
- •Patients with active opportunistic diseases.
- •Patients coinfected with HCV.
- •Patients without tonsillar tissue.
- •Treatment with other drugs receptor antagonists or angiotensin II converting enzyme inhibitors, angiotensin II.
- •Kidney failure.(Glomerular Filtration Rate (GFR < 60 mL/mn)
- •Severe liver failure (PT> 60% ).
- •Pregnant women
- •Known hypersensitivity or contraindication to any study drug.
- •determination of blood pressure (BP) <100/60 mmHg
- •Hyponatremia with serum Na numbers <132 Meq / l
- •History of chronic vomiting the last 6 months
- •History of chronic diarrhea the last 6 months
研究组 & 干预措施
EFV/FTC/TDF
干预措施: EFV/FTC/TDF (Drug)
EFV/FTC/TDF + Losartan
干预措施: EFV/FTC/TDF + Losartan (Drug)
FTC/TDF + MK-0518
干预措施: FTC/TDF + MK-0518 (Drug)
FTC/TDF+MK-0518+Losartan
干预措施: FTC/TDF+MK-0518+Losartan (Drug)
结局指标
主要结局
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
时间窗: 48 weeks
次要结局
- Proportion of Patients With Changes in the Levels of CRP in Different Groups.(48 weeks)
- Proportion of Patients With Increased CD4 in Peripheral Blood.(48 weeks)
- Proportion of Patients With Increased CD4 in Lymphatic Tissue.(week 48)
- Proportion of Patients With Undetectable Plasma Viral Load in Different Groups(48 weeks)
- Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.(48 weeks)
- Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.(48 weeks)
- Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups(week 48)
- Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.(48 weeks)
- Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.(48 weeks)
- Proportion of Patients With Changes in Levels of Metalloproteinases(48 weeks)
- Proportion of Patients With Changes in Levels of beta2-microglobulin.(48 weeks)
- Proportion of Patients With Changes in Levels of CSF Cells.(48 weeks)
- Proportion of Patients With Changes in Levels of Proteins.(48 weeks)
- Proportion of Patients With Improvement in Neuropsychological Test(48 weeks)
- Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.(up to 48 weeks)
- Changes in CD4 CD38+ HLADR+ (%)(0, 48 weeks)
研究者
Felipe Garcia
Dr
Hospital Clinic of Barcelona