Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Time to viral rebound
研究概览
简要总结
The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Although the kinetics of HIV rebound should allow observing differences between placebo and control regarding the post treatment controls rate in case of efficacy of the IMPs, assessing the length and determinants of a post-intervention control (PIC) (i.e., associated with vaccination) beyond 24 weeks is crucial for developing a curative approach to HIV infection. In this regard, an extension of the ATI phase for those individuals with pVL less than 2,000 copies/mL after 24 weeks of ATI in the AELIX-002 offers an unique research opportunity to better understand relevant aspects of the mechanisms involved in the different phenotypes of a PIC and PTC.
详细描述
The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Although the kinetics of HIV rebound should allow observing differences between placebo and control regarding the post treatment controls rate in case of efficacy of the IMPs, assessing the length and determinants of a post-intervention control (PIC) (i.e., associated with vaccination) beyond 24 weeks is crucial for developing a curative approach to HIV infection. In this regard, an extension of the ATI phase for those individuals with pVL less than 2,000 copies/mL after 24 weeks of ATI in the AELIX-002 offers an unique research opportunity to better understand relevant aspects of the mechanisms involved in the different phenotypes of a PIC and PTC.
This trial will enrol participants of the AELIX-002 clinical trial regardless of whether they received vaccines or placebo, who reach 24 weeks of ATI with pVL <2,000 cop/ml and are willing to remain off cART. After accepting participation, subjects will undergo a one-year extension [48 weeks] of ATI monitoring (total duration of ATI envisioned will be of 72 weeks [24 weeks in AELIX-002 study + 48 weeks in current study]), followed by 24 weeks of safety follow-up after cART is resumed.
The primary objective of this study is to assess the safety and durability of viral control after AELIX-002 clinical trial intervention beyond 6 months of ATI. Furthermore, the study will collect biological samples to be stored for further investigational studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
AELIX-002 was a double-blind clinical trial. During ATI_extension, AELIX-002 will be unblinded and allocation will be disclosed to both participants and investigators.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of the AELIX-002 clinical trial at week 24 of ATI:
- •Willing to continue the ATI up to 1 year.
- •With pVL <2,000 copies/ml at week 24 of ATI on the AELIX-002 study.
- •CD4 count ≥350 cells/mm3 at week 24 of ATI on the AELIX-002study.
- •Willing to comply with the measures to prevent HIV transmission and reinfection required by the protocol.
- •Available for follow-up for the planned duration of the ATI period of this study.
- •Willing to accept blood draws and collect stool at time points specified in the Schedule of Procedures.
- •If heterosexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device
- •(IUD), or anatomical sterility in self or partner1) during the ATI and until her pVL is <50 copies/ml after cART resumption.
- •If heterosexually active male; using an effective method of contraception (anatomical sterility in self) or agree on the use of an effective method of contraception by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical
- •sterility1) during the ATI and until his pVL is <50 copies/ml after cART resumption.
- •Not willing to donate blood during the study.
- •Participants who understand the information provided, in the opinion of the investigator.
排除标准
- •1- Pregnancy or breastfeeding.
- •History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study.
- •Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.
- •Active hepatitis B or C at week 24 of ATI on the AELIX-002 study.
- •Risk of HIV transmission (i.e. repeated STI during the AELIX-002 ATI period or reported unprotected anal sex).
结局指标
主要结局
Time to viral rebound
时间窗: up to 72 weeks after start of ATI
Time to viral rebound up to 72 weeks after start of ATI, defined as the time from ATI start to first occurrence of ≥ 2,000 copies/ml.
Percentage of participants with viral control
时间窗: week 72
Percentage of participants with viral control, defined as a pVL \<2,000 copies/ml at 72?weeks after start of ATI.
Time to viral detection
时间窗: up to 72weeks after start of ATI
Time to viral detection up to 72 weeks after start of ATI, defined as the time from ATI start to first occurrence of detectable pVL (≥50 copies/ml).
Percentage of participants with viral remission
时间窗: week 72
Percentage of participants with viral remission, defined as plasma viral load (pVL) \<50 copies/ml at 72 weeks after start of ATI.
Time off cART
时间窗: From ATI start to week 72
Time off cART, defined as time to cART resumption from ATI start.
Percentage of participants who remain off cART
时间窗: Week 72
Percentage of participants who remain off cART at 72 weeks after ATI start.
次要结局
- The proportion of participants who develop symptoms compatible with acute retroviral syndrome.(From ATI start to week 72)
- The proportion of participants who suppress pVL to <50 copies/ml(24 weeks after cART resumption)
- The proportion of participants who develop new mutations not present in the pre-cART genotype(24 weeks after cART resumption)
- Change in a score for ATI psychological impact(At weeks 24, 48 and at week 4 post cART resumption (or at the End of ATI visit in case of early withdrawal).)
- Phenotypes characterization(From ATI start to week 72)
- Description of participants who develop AEs related to the prime- boost regimen during this extension of ATI period.(From ATI_extension start to week 72)