Efficacy of dolutegravir based antiretroviral regimen in HIV positive children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Proportion of patients having viral suppression after 6 months of treatment with Dolutegravir based regimen.
研究概览
简要总结
This study is an observational study aimed at finding the efficacy of Dolutegravir based antiretroviral regimen in HIV positive children aged between 1 month to 15 years. Study will be conducted in Paediatric HIV clinic, Maulana Azad Medical College and associated Lok Nayak Hospital, Delhi.
Primary outcome of the study will be the proportion of patients having viral suppression after 6 months of treatment with Dolutegravir based regimen.
Secondary outcomes of the study will be:
-
Proportion of patients having adverse events (if any) following treatment with Dolutegravir based regimen and grading of the severity of adverse events.
-
Proportion of patients adherent to treatment with Dolutegravir based regimen.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients substituted to Dolutegravir based regimen from older treatment regimens.
- •Newly diagnosed HIV positive children started on DTG regimen.
排除标准
- •Coinfection with Tuberculosis, Hepatitis B and Hepatitis C.
- •Patients with chronic liver disease and auto immune diseases.
结局指标
主要结局
Proportion of patients having viral suppression after 6 months of treatment with Dolutegravir based regimen.
时间窗: 6 months
次要结局
- 1. Proportion of patients having adverse events (if any) following treatment with dolutegravir based regimen and grading of severity of adverse events.(2. Proportion of patients adherent to treatment with Dolutegravir based regimen.)
研究者
Vijaya lakshmi Minumanuri
Maulana Azad Medical College