Study of the efficacy and safety of Dolutegravir based first line anti-retroviral Therapy in people living with HIV infection.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To determine whether a statistically significant reduction in viral load and a statistically significant increase in CD4 cell count happens when compared with the previous regimen
研究概览
简要总结
This study will be a single center, open label, retrospective as well as prospective cohort study. Total sample size is 1000. after obtaining the written and informed consent from the patient, Detailed history shall be taken from the subjects to see the signs and symptoms of other opportunistic infections, MTB, Diabetes Mellitus, Hypertension, Lipodystrophy, HBV, HCV infection. Patients shall be followed up regularly at the ART center. Adherence, side effects body weight shall be documented. Viral and CD4 shall be documented at 6 and 12 monthly.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Minimum 1000 patients for retrospective and prospective studies with confirmed and documented HIV1 infection on Dolutegravir, Lamivudine and Tenofovir Alafenamide.
排除标准
- •Patients on 2nd, 3rd, other regimens and patients not giving consent to the study.
结局指标
主要结局
To determine whether a statistically significant reduction in viral load and a statistically significant increase in CD4 cell count happens when compared with the previous regimen
时间窗: Both viral load and CD4 count measured at 6 and 12 months after starting the regimen
次要结局
- To determine statistically significant adverse events once the treatment is started(Follow up at 6 months & 1 year)
研究者
Amol Prakash Dehade
Institute of Medical Sciences, B.H.U.