Long-Term Supervised Treatment Interruption in HIV-Infected Patients Who Started Antiretroviral Treatment With CD4 Over 350/mm3 and Plasma HIV RNA Below 50 000/mL ANRS 116 Trial SALTO
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Proportion of patients who did not resume antiretroviral treatment at 12 months
研究概览
简要总结
This trial is aimed at studying the safety of long term supervised treatment interruption in HIV infected patients with CD4 over 350/mm3 and plasma HIV RNA under 50 000/mL. Another aim of this study is to assess the immunological and virological factors associated with the duration of treatment interruption.
详细描述
The limitations of the drugs used against HIV include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection are associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart.
In patients with high CD4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving HAART now in whom treatment would not have been started based on current guidelines), we evaluated the safety of long term supervised treatment interruption. Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral HIV DNA at baseline and during follow-up, plasma HIV RNA at baseline and during follow-up, CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Males and non pregnant females
- •18 years of age and older
- •Who have confirmed laboratory diagnosis of HIV infection
- •Started on first line antiretroviral treatment with CD4 over 350/mm3 and plasma HIV RNA below 50 000/mL
- •Ongoing Antiretroviral therapy at inclusion with CD4 over 450/mm3 and plasma HIV RNA below 5000/mL
排除标准
- •HBV-HIV co-infection receiving lamivudine therapy
- •Ongoing immunotherapy including IL2, interferon or HIV specific vaccine
- •Pregnancy or project of pregnancy
结局指标
主要结局
Proportion of patients who did not resume antiretroviral treatment at 12 months
次要结局
- Predictive factors associated with the time of restart of antiretroviral therapy: Proviral HIV DNA at baseline and during follow-up
- Change in lipodystrophy clinical score and quality of life during the follow-up
- Time to resume antiretroviral treatment with CD4 cell count equal or below 300/mm3
- Criteria to resume antiretroviral treatment: CD4T cell count below or equal to 300/mm3
- The occurrence of an AIDS defining event
- Proportion of patients who did not resume antiretroviral treatment at M 24 and M 36
- Plasma HIV RNA at baseline and during follow-up
- CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months