CTRI/2018/05/014117进行中（未招募）4 期
A Phase IV, Open Label, Non-Comparative, Multicenter study to access Safety and Tolerability of Darunavir Ethanolate 800mg tablets once daily co-administered with Ritonavir 100mg tablets once daily and other Anti-Retroviral agents in adults subjects with Human Immunodeficiency Virus (HIV-1) infection
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Cipla Ltd
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Audio consent and a written signed dated informed consent from subjects and/or legally acceptable representative
- •2. Either gender with age 18 years and above
- •3. Subjects with human immunodeficiency virus (HIV -1) infection who are treatment-experienced adult patients with no Darunavir resistance associated substitutions
- •(V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V)
排除标准
- •1. Known hypersensitivity to Darunavir Ethanolate or Ritonavir or any of its components or other anti-retroviral agents given concomitantly
- •2. Subjects with sulfa allergy
- •3. Pregnancy or breastfeeding
- •4. Severe Hepatic Impairment Child Pugh Class C
- •5. Concomitant use of drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index)
- •6. Subject unsuitable to participate in the study as per the discretion of investigator
研究者
相似试验
已完成
4 期
SYNRIAM tablets in MalariaCTRI/2015/07/006050Sun Pharmaceutical Industries Limited400
进行中（未招募）
不适用
A phase IV, open label, non comparative, multicenter study to evaluate the long term efficacy and safety and tolerability of oral miglustat as a maintenance after a switch form enzyme replacement therapy ERT in adult patients with stable type 1 Gaucher disease - NDEUCTR2005-001651-37-ITActelion Registration Ltd50
进行中（未招募）
1 期
Immunogenicity and safety study of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix™ during pregnancy or immediately post-delivery.EUCTR2014-001117-41-FIGlaxoSmithKline Biologicals680
进行中（未招募）
1 期
Evaluation of immunogenicity and safety of a booster dose of Infanrix hexa™ in healthy infants born to mothers vaccinated with Boostrix™ during pregnancy or immediately post-delivery.Infanrix Hexa is indicated for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib).EUCTR2014-001120-30-Outside-EU/EEAGlaxoSmithKline Biologicals680
进行中（未招募）
1 期
Evaluation of immunogenicity and safety of a booster dose of Infanrix hexa™ (217744) in healthy infants born to mothers vaccinated with Boostrix™ during pregnancy or immediately post-delivery.Infanrix Hexa is indicated for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib).EUCTR2014-001120-30-CZGlaxoSmithKline Biologicals SA,680