Efecto de la Isoprinosina en Pacientes Con infección Por VIH y Carga Viral Entre > 50 y < 200 Copias/mL de la Unidad de atención de PVV Del Hospital Enrique Garcés en Quito, Ecuador Durante el año 2019.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Viral load
研究概览
简要总结
Virological failure is a complication of treatment in patients with HIV, and it can be as high as 42% to first line treatment or around 18% in second line treatment. The reasons behind this phenomenon are several, including adherence to treatment (self-patient) or those related to the drugs (kinetics, interactions) and the virus itself (resistance patterns). People living with HIV needs treatment for all their lives, another factor to facilitate virus resistance and poor adherence to treatment. For that reason, it is necessary to look for additional therapeutic options to minimize this problem, and the use of immunomodulatory drugs is an interesting topic now. Among those drugs, isoprinosine hs been reported not only improve the immune response, it also has the capability to inhibit the replication of RNA virus. Then, we propose an open label clinical trial to evaluate the effect of isoprinosine in HIV patients with a virological load between 50 and 200 copies/ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Older than 18 years old.
- •Patients with a viral load (RNA of VIH) between > 50 and < 200 copies/mL after 24 weeks of antiviral therapy or after scheme change.
- •Informed consent signature
排除标准
- •Younger than 18 years old.
- •No virologic failure or RNA of VIH > 200 copies/mL.
- •Presence of a serious opportunistic infection.
- •Renal failure (including litiasis) or presence of gout.
- •Pregnancy.
研究组 & 干预措施
Immunomodulator group
Metisoprinol 1 gr every 8 h per ten days during three months plus the combine antiretroviral therapy.
干预措施: Metisoprinol (Drug)
结局指标
主要结局
Viral load
时间窗: Change from Baseline viral load at 3 months
Number of viral copies/mL
次要结局
- CD4+ count(Change from Baseline CD4+ count at 3 months)
研究者
Enrique Teran
Professor
Universidad San Francisco de Quito