A I//II Phase Study of the Efficacy and Safety of Interferon-Gamma by Subcutaneous Injection in the Complex Treatment of Patients Infected With HIV and Tuberculosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Sputum Culture
研究概览
简要总结
The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.
详细描述
Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.
Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.
The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.
The treatment regimen in this study will also include a basic antituberculosis therapy.
The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must sign the form of informed consent and agree to follow the protocol requirements
- •Women willing to participate in the study must protect against possible pregnancy during all the study long
- •Age 18-50 years
- •Pulmonary tuberculosis
- •Indication for in-patient standard antituberculosis treatment
排除标准
- •Investigational research agents received within 30 days before the screening and participation in other clinical trials
- •Immunosuppressive medications received within 6 months before the screening
- •Current drug abuse for more than 3 years
- •Contraindications to interferons of standard antimicrobial therapy
研究组 & 干预措施
Interferon
All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy
干预措施: Interferon-Gamma (Drug)
Interferon daily
All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy
干预措施: Interferon-Gamma (Drug)
结局指标
主要结局
Sputum Culture
时间窗: Week 4
Precentage of participants with negative sputum culture
次要结局
- CD4(Screening, Week 4)
- CD8(Screening, Week 4)
- Leucocytes Level(Screening, Week 4)
- CD3(Screening, Week 4)
- Average Hemoglobin Level(Screening, Week 8)
- CD4/CD8(Screening, Week 4)