Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy (ART) With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Plasma inflammatory markers
研究概览
简要总结
HIV-infected patients develop comorbidities earlier than the general population. Immune activation with the secretion of pro-inflammatory cytokines would play a major role in the occurrence of these comorbidities. Numerous factors, called risk factors, already identified in the general population and confirmed in patients with HIV virus favor the occurrence of these comorbidities but cannot alone explain the overrepresentation and precocity of these comorbidities in the HIV population. Investigators hypothesize that optimization or simplification with certain classes of antiretrovirals modify the inflammatory response and are predictive factors for the occurrence of comorbidities
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •HIV-1 infection
- •Age > 40 years or adults with more than 10 years of antiretroviral therapy
- •Switching to BIC/FTC/TAF or DTG/3TC or DTG+3TC within the last 2 years
- •Plasma HIV-1 RNA viral load < 50 copies/ml for more than 6 months
- •Absence of chronic hepatitis B infection
- •Absence of genotype mutations on Dolutegravir (DTG) or Bictegravir (BIC) or tenofovir alafenamide TAF
- •Daily use of antiretroviral therapy
- •Effective contraception for women of childbearing potential will be requested
- •Signed informed consent
- •Enrollment in a Social Security plan
排除标准
- •Non-daily or intermittent antiretroviral therapy regimen (e.g., 4 or 5 days a week)
- •Pregnancy or breastfeeding
- •Vulnerable persons according to article L.1121-6 of the public health code Persons unable to give consent according to article L.1121-8 of the public health code
- •Opportunistic infections during curative treatment
- •HIV-2 infection
- •Active hepatitis C
- •Refusal to participate
- •Withdrawal of informed consent by the patient
研究组 & 干预措施
patients on antiretroviral therapy with second generation anti-integrase drugs in triple therapy
干预措施: CD4/CD8 ratio (Other)
patients on antiretroviral therapy with second generation anti-integrase drugs in triple therapy
干预措施: plasma inflammatory markers (Other)
patients on antiretroviral therapy with second generation anti-integrase drugs in dual therapy
干预措施: plasma inflammatory markers (Other)
patients on antiretroviral therapy with second generation anti-integrase drugs in dual therapy
干预措施: CD4/CD8 ratio (Other)
结局指标
主要结局
Plasma inflammatory markers
时间窗: 3 years after baseline
To measure the evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB) over 3 years between the 2 groups.
CD4/CD8 ratio
时间窗: 3 years after baseline
To measure the evolution of CD4/CD8 ratio over 3 years between the 2 groups. A CD4/CD8 ratio is considered normal if it is greater than 0.75. Immune hyperactivation occurs when the ratio is below 0.75
次要结局
- Virological failure rate (year 1)(One year after baseline)
- residual viremia rate (year 1)(One year after baseline)
- plasma markers assay (year 1)(1 year after baseline)
- plasma markers assay (year 2)(2 years after baseline)
- comorbidities (year 2)(2 years after baseline)
- patient profiles(3 years after baseline)
- Virological failure rate (year 3)(three years after baseline)
- plasma markers assay (year 3)(3 years after baseline)
- risk factors for immune hyper activation(3 years after baseline)
- comorbidities (year 1)(1 year after baseline)
- individualized and computerized care plan(3 years after baseline)
- Prevalence of neuropsychiatric events at 3 years(3 years after baseline)
- changes in antiretroviral therapy (year 2)(2 years after baseline)
- Onset of new comorbidity(3 years after baseline)
- Virological failure rate (year 2)(two years after baseline)
- Residual viremia rate (year 2)(two years after baseline)
- Prevalence of neuropsychiatric events at 1 year(1 year after baseline)
- changes in antiretroviral therapy (year 1)(1 year after baseline)
- Evolution of intracellular markers (CD8/CD38, HLA-DR) (year 1)(1 year after baseline)
- immune activation markers assays and identification of comorbidities(3 years after baseline)
- comorbidities (year 3)(3 years after baseline)
- Residuak viremia rate (year 3)(3 years after baseline)
- Prevalence of neuropsychiatric events at 2 years(2 years after baseline)
- changes in antiretroviral therapy (year 3)(3 years after baseline)