Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection
研究概览
简要总结
The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.
详细描述
Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions.
After HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004).
We hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.
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 with acute or primary HIV-1 infection
- •Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p
- •Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and < 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.
- •Symptomatic Primary infection or CD4 <500/mm3
- •written informed consent
- •≥ 18 years old
排除标准
- •Prior post exposure antiretroviral treatment within six months before enrolment
- •Pregnancy or breast-feeding
- •HIV-2 infection
- •Current malignancy
- •Prothrombin time < 50%
- •Creatinine clearance < 60 ml/min
- •ASAT, ALAT or bilirubin ≥10*N
- •Platelets < 25000/mm3
研究组 & 干预措施
arm 1
darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
干预措施: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine (Drug)
arm 2
darunavir, ritonavir, emtricitabine/tenofovir
干预措施: darunavir; ritonavir; emtricitabine/tenofovir (Drug)
结局指标
主要结局
To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection
时间窗: 24 months
次要结局
- Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24(24 months)
- Evolution of the CD4 and CD8 between D0 and M24(24 months)
- Number and type of ARV mutations in virological failures and change in CCR5 tropism(24 Months)
- Changes in cell-associated HIV-DNA between baseline and M24(24 Months)
- Tolerability of trial treatments(24 months)
- Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30(30 months)