Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
- 主要终点
- Number and severity of AEs and SAEs
研究概览
简要总结
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution in HIV infected subjects treated with HAART.
详细描述
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution expressing triple targets antibodies with broad HIV-1 neutralizing activity in HIV-1 infected adults on anti-retroviral therapy (ARV). Nine subjects will be enrolled and administered with three different doses of KL-HIV-Tri01. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL-HIV-Tri01. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL-HIV-Tri01 for total 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 (not inclusive) to 80 (inclusive) years of age, both male and female.
- •Conform to the Chinese AIDS Diagnosis and Treatment Guidelines (2021), HIV positive, and received HAART treatment for ≥ 3 months before enrollment.
- •CD4+T cell count≥500 cells/μl.
- •On a stable antiretroviral regimen before enrollment and viral load less than 40 copies/mL in two consecutive tests one year prior to enrollment.
- •Willing to fully understand the purpose, nature, method, and potential adverse reactions that may occur during the discontinuation period of the experiment, voluntarily participate in this experiment and sign an informed consent form.
排除标准
- •Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- •Active viral infections, such as HBV, HCV, CMV, or other viruses that the investigator believes will affect clinical research.
- •Any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment.
- •Currently treated with Immunosuppressive medications or steroids.
- •Previous receipt of HIV vaccine, antibody or gene therapy.
研究组 & 干预措施
KL-HIV-Tri01 injection solution
Subjects will be dosed with three different dose of KL-HIV-Tri01 injection solution at 2.4x10^11 vg/kg to 2.4x10^12 vg/kg.
干预措施: Low dose KL-HIV-Tri01 (Drug)
KL-HIV-Tri01 injection solution
Subjects will be dosed with three different dose of KL-HIV-Tri01 injection solution at 2.4x10^11 vg/kg to 2.4x10^12 vg/kg.
干预措施: Middle dose KL-HIV-Tri01 (Drug)
KL-HIV-Tri01 injection solution
Subjects will be dosed with three different dose of KL-HIV-Tri01 injection solution at 2.4x10^11 vg/kg to 2.4x10^12 vg/kg.
干预措施: High dose KL-HIV-Tri01 (Drug)
结局指标
主要结局
Number and severity of AEs and SAEs
时间窗: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
AEs and SAEs from the date of product administration will be recorded through the last study visit. The relationship between AEs and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol.
Neutralizing Antibodies Against KL-HIV-Tri01 Capsid
时间窗: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Anti-KL-HIV-Tri01 Capsid antibodies were analyzed by enzyme-linked immunosorbent assay (ELISA) using a vector-matched AAV capsid as the capture agent.
Inhibitors of broadly neutralizing antibodies
时间窗: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Inhibitors against broadly neutralizing antibodies expressed by KL-HIV-Tri01 were analyzed by enzyme-linked immunosorbent assay (ELISA) .
Cells mediated immune response against capsids and bNabs
时间窗: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Number of participants with T-cell response to AAV capsid and transgene products was planned to be reported.
次要结局
- Concentration and titer of serum neutralizing antibodies(Day 0 through 52 Weeks after KL-HIV-Tri01 administration)
- CD4+T, CD8+T cell count(Day 0 through 52 Weeks after KL-HIV-Tri01 administration)
- viral load(Day 0 through 52 Weeks after KL-HIV-Tri01 administration)
- Time to interrupt HAART treatment(Day 0 through 52 Weeks after KL-HIV-Tri01 administration)
研究者
Honghua He
Associated chief physician
Affiliated Hospital of Guangdong Medical University