Long-term Safety of Subjects Continuing Dolutegravir After Participation in Clinical Studies of Dolutegravir in Russian Federation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of subjects with drug related Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
DTG 50 milligram (mg) tablet was approved for marketing in Russian Federation; however, DTG is not currently available for subjects at Acquired Immune Deficiency Syndrome (AIDS) Centers as it is not available for order and supply via Federal program. This study is an open-label study which will include subjects, who complete taking DTG in studies ING112276, ING113086, ING114915, ING111762, and those subjects who end participation in study 200304 in which they received either DTG or lopinavir/ritonavir (LPV/RTV). DTG will be supplied at a dose of 50 mg once daily to eligible subjects until the subject stops taking DTG or transitions to commercial supply of DTG when available at AIDS Centers via the Federal program. The objective of this study is to bridge the gap between the closure of ING112276, ING113086, ING114915, ING111762 or end of subject's participation in 200304 and the actual availability of commercial DTG at AIDS Centers via Federal program for human immunodeficiency (HIV)-1-infected adult subjects in Russian Federation. The study will also investigate long-term safety of DTG for subjects continuing DTG in Russian Federation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must complete an End of Study (EOS) visit for the originating protocol ING112276, ING113086, ING114915, ING111762, or be withdrawn from 200304 and attend withdrawal visit prior to transitioning to this study.
- •Documented evidence of plasma HIV-1 RNA measurement <50 c/mL at the EOS visit in ING112276, ING113086, ING114915, ING111762, 200304 (for subjects receiving DTG ) and <400 c/mL for subjects prior receiving LPV/RTV in
- •Based on medical assessment by the subject's Principal Investigator, the subject continues to derive clinical benefit from treatment with DTG as part of combination antiretroviral therapy (cART) and demonstrates stable virologic success. For subjects, currently receiving LPV/RTV and finishing their participation in 200304, possibility to derive clinical benefit from treatment with DTG is assessed by Principal Investigator following recommendation of Independent Data Monitoring Committee (IDMC).
- •Subjects must be capable of giving signed informed consent to participate in this study.
排除标准
- •Subjects not currently enrolled in clinical study ING112276, ING113086, ING114915, ING111762, 200304 are not eligible for this study.
- •Subjects for whom confirmed virologic withdrawal criteria were met in ING112276, ING113086, ING114915, ING111762, 200304 are not eligible.
- •In addition to the above mentioned criteria, investigator/physician must confirm that the subject has no prohibited clinical condition (other medicines or other health conditions, such as hepatic or renal contra-indications). Further, all women of child bearing potential must be cautioned that DTG is not approved for use in pregnancy, and be advised that birth control measures should be in place while taking DTG. Subjects who were permanently discontinued from DTG in the previous study due to intolerance must not be included in this study.
研究组 & 干预措施
HIV positive subjects continuing DTG
HIV positive subjects who complete taking DTG in studies ING112276, ING113086, ING114915, ING111762 and those subjects who end participation in study 200304 in which they received either DTG or LPV/RTV will be included in this study.
干预措施: Dolutegravir 50 mg (Drug)
结局指标
主要结局
Number of subjects with drug related Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 7 months approximately
Drug related AE is defined as all untoward and unintended responses to an investigational medicinal product related to any dose administered. All AEs will be graded according to Division of AIDS (DAIDS) toxicity scale.
Number of subjects with abnormal hematology parameters
时间窗: Up to 7 months approximately
Hematology parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Number of subjects with abnormal clinical chemistry parameters
时间窗: Up to 7 months approximately
Clinical chemistry parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Number of subjects with abnormal urine parameters
时间窗: Up to 7 months approximately
Urine parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Number of subjects with abnormal electrocardiogram (ECG)
时间窗: Up to 7 months approximately
The number of subjects with abnormal ECG results will be summarized.
Number of subjects with abnormal radiological scan
时间窗: Up to 7 months approximately
The number of subjects with abnormal radiological scan will be summarized.
Number of subjects with abnormal physical examination
时间窗: Up to 7 months approximately
The number of subjects with abnormal physical examination will be summarized
Number of subjects achieving HIV-1 ribonucleic acid (RNA) suppression < 50 copies per milliliter (c/mL)
时间窗: Up to 7 months approximately
Efficacy of DTG will be assessed at routine clinical practice based on the maintenance of HIV-1 RNA suppression at \<50 c/mL.
Number of subjects with abnormal blood pressure
时间窗: Up to 7 months approximately
The number of subjects with abnormal blood pressure will be summarized.
Number of subjects with abnormal heart rate
时间窗: Up to 7 months approximately
The number of subjects with abnormal heart rate will be summarized.
Number of subjects with abnormal temperature
时间窗: Up to 7 months approximately
The number of subjects with abnormal body temperature will be summarized.
Number of subjects with abnormal respiratory rate
时间窗: Up to 7 months approximately
The number of subjects with abnormal respiratory rate will be summarized.
Number of subjects receiving concomitant medications
时间窗: Up to 7 months approximately
All the concomitant medications that the subject will receive will be evaluated.
次要结局
未报告次要终点