A Prospective Single-arm Cohort Study Evaluating the Safety and Efficacy of Thymalfasin (Zadaxin®) in the Treatment of HIV-positive Patients With Immune Reconstitution Disorders
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in CD4+T cell counts
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Zadaxin® in the treatment of HIV-positive patients with immune reconstitution disorders. Researchers previously used Zadaxin® (Thymosin α-1, Tα1) as an immune adjuvant for people infected with HIV-1 and found that Tα1 and Interferon-α (IFN-α) have a synergistic effect in immune enhancement. In addition, studies have found that the triple combination of Tα1, IFN-α and Zidovudine has better tolerability, safety and efficacy. After treatment, patients have lower HIV RNA and more stable high CD4+ T cell counts. In addition, extensive studies on the administration of Tα1 in thymectomized mice have demonstrated its ability to promote immune reconstitution. The researchers hypothesized that Zadaxin® has a better therapeutic effect on HIV-positive patients with immune reconstitution disorders, can increase the CD4+T cell count, reduce the viral load, and has better safety.
详细描述
All patients received Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive 22 weeks. It is still recommended to continue treatment until the end of the study. All subjects were given HAART treatment throughout. In 4th week, 8th week, 12th week and 24th week, perform 4 follow-up and record the changes in CD4+ T cell count and proportion, CD8+ T cell count and proportion, proportions of T cell subsets, PBMC sjTREC, proportions of exhauseted T cell expressed PD-1 and Tim-3, and HIV viral load. During the process, safety assessment is performed, including adverse events, electrocardiogram and a series of laboratory tests (blood routine, liver and kidney function, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old;
- •HIV serology is positive;
- •Volunteer to participate;
- •CD4+T cell count >100 and <350 cells/mm3;
- •People who have received HAART treatment and the viral load is undetected for at least 2 years, but have immune reconstitution disorder;
- •Without active opportunistic infection;
排除标准
- •History of allergy or contraindications to Zadaxin;
- •Skin basal cell carcinoma, cervical carcinoma in situ or other concurrent tumors other than Kaposi's sarcoma;
- •The expected survival time is less than 1 year;
- •Women of childbearing age have a positive pregnancy test;
- •Major heart disease or central nervous system disease or other nervous system abnormalities;
- •ACTG-AIDS dementia syndrome staging score> 0.5;
- •Organ transplantation;
- •Received chemotherapy and radiotherapy for malignant tumors within 6 months;
- •Known immunomodulators (such as systemic steroids, interferons, interleukins) or other immunotherapy within 30 days before the start of the study;
- •Blood transfusion within 30 days before the start of the study;
- •Have a history of iritis, endophthalmitis, scleritis or retinitis;
- •Within 30 days before the screening assessment, accept any experimental treatment for HIV-positive patients with or without symptoms of infection;
- •Drug abuse;
- •The doctor's decision is that participation in the trial is not in the patient's best interests, or any situation that does not allow safe compliance with the protocol.
研究组 & 干预措施
Zadaxin-HIV(n=20)
Study participants will be given Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive 22 weeks.
干预措施: Zadaxin (Drug)
结局指标
主要结局
Change in CD4+T cell counts
时间窗: Measured on week 24
Peripheral blood
Change in CD4/CD8 ratio
时间窗: Measured on week 24
Peripheral blood
次要结局
- Change in CD4+T cell count and proportion(Measured on week 0, 4, 8, 12, 24)
- Change in HIV-1 RNA(Measured on week 0, 4, 8, 12, 24)
- Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3(Measured on week 0, 4, 8, 12, 24)
- Change in PBMC sjTREC(Measured on week 0, 4, 8, 12, 24)
- Change in CD8+T cell count and proportion(Measured on week 0, 4, 8, 12, 24)
- Change in proportions of T cell subsets(Measured on week 0, 4, 8, 12, 24)
研究者
Hongzhou Lu
Professor
Shanghai Public Health Clinical Center