A Post-Marketing Surveillance Study on the Safety and Effectiveness of Darunavir on Filipino Patients With Human Immunodeficiency Virus-Type I (HIV-1) Infection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of patients with incidence of adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical and observational study (study in which the investigators/physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino patients. The study will enroll 10 percentage of patient who would use the product, as a requirement of the Philippine Food and Drug Administration (FDA). Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study. The duration of treatment will be for 24 weeks and the total study will be conducted for 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment. These may be either: treatment-naive adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions; or treatment-experienced adult patients with at least one darunavir resistance associated substitution
排除标准
- •Known hypersensitivity to darunavir/ritonavir or to any of the components of the two agent preparations
- •Pregnant or breastfeeding females
- •Agrees to protocol-defined use of effective contraception
- •Patients taking medication that are highly dependent on Cytochrome P450 3A4 for clearance and for which initial concentrations are associated with serious and/or life threatening events
- •Patients with severe hepatic impairment
- •History of allergy to sulfa containing drugs or molecules
- •Patients currently receiving alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonavine, cisapride, pimozide, midazolam, triazolam, St. John's Wort (Hypericum perforatum), lovastatin, simvastatin, rifampin and sildenafil
研究组 & 干预措施
Darunavir
Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.
干预措施: No intervention (Drug)
结局指标
主要结局
Number of patients with incidence of adverse events
时间窗: Up to 24 weeks
Number of patients with incidence of discontinuation of study medication due to adverse events
时间窗: Up to 24 weeks
次要结局
- Mean decrease of viral load at the end of treatment from baseline(Baseline, Week 12, and Week 24)
- Number of patients with viral load of 50 copies per ml at the end of treatment(Baseline, Week 12, and Week 24)
- Number of patients with lack of effect(Up to 24 weeks)