Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China: A Multicenter Post-Marketing Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 98
- 试验地点
- 5
- 主要终点
- Evolution of the HIV Viral Response
研究概览
简要总结
This post-marketing observational study is conducted for obtaining data on clinical, biological and virological outcomes, compliance and tolerability of using a lopinavir/ritonavir (LPV/r) -containing regimen for the treatment of naïve or experienced patients infected with human immunodeficiency virus type 1 (HIV-1) in China.
Although LPV/r is frequently used world-wide, the evaluation of the outcomes, compliance, and tolerance of anti-HIV strategies in real life is still a major challenge in the management of HIV-infected patients who are on a life-long therapy, especially in China.
This study will help to develop effectiveness and safety profile of the lopinavir/ritonavir containing regimen in Chinese HIV-1 infected patients, provide more choices of anti-HIV-1 strategies to Chinese experts and benefits Chinese HIV-1 infected patients.
详细描述
It is planned to enroll approximately 100 patients in total. This will be a multicenter post-marketing observational study in China mainland.
Each patient will be observed during his/her lopinavir/ritonavir - containing treatment regimen for a maximum period of 18 months.
If the physician decides to permanently discontinue lopinavir/ritonavir before the end of the planned observational period of 18 months, the reason for the discontinuation and the new treatment regimen prescribed will be documented. The next routine follow-up visit will be the termination visit for this patient in this study.
This post-marketing observational study will be conducted in a prospective, single-arm, multicenter format.
As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 18-month period, which defines the survey for each patient. For indicative purpose, follow-up of patients should enable approximately 4 patient visits during this period. These visits will take place at average intervals of 6 months, apart from the first visit following inclusion (usually at the end of the first 3 treatment months) and apart from visits required because of an intercurrent event. If treatment with lopinavir/ritonavir is discontinued, standard practice is to review the patient after a period of 3 months.
研究设计
- 研究类型
- Observational
- 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 infected by HIV-1 who are over 18 years old
- •Patients who belong to one of the following cohorts:
- •Antiretroviral naïve patients
- •Antiretroviral experienced patients, irrespective to their immune and viral status and current antiretroviral therapy
排除标准
- •Patients who have been treated with lopinavir/ritonavir
- •Patients who are being treated or will be treated with drugs at risk of interactions with lopinavir/ritonavir
- •Patients who are not tolerant to lopinavir/ritonavir
- •Patients who have uncontrolled AIDS defining disease
- •Patients participating in another clinical trial
研究组 & 干预措施
Lopinavir/ritonavir group
This study is a non-interventional, observational study in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of China market authorization with regards to dose, population and indication. It is planned to enroll approximately 100 patients in total.
干预措施: Lopinavir/ritonavir (Kaletra) (Drug)
结局指标
主要结局
Evolution of the HIV Viral Response
时间窗: Month 3, 6, 12, 18
The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.
Evolution of CD4 Count
时间窗: Month 3, 6, 12, 18
The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ count results are reported as the number of CD4+ cells per cubic millimeter (cmm). Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.
Evolution of the Tolerance Issues
时间窗: Month 3, 6, 12, 18
At each study visit, treating physicians evaluated participants and used their clinical judgment to determine if they were tolerating the lopinavir/ritonavir-containing regimen. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.
次要结局
- Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen(Month 3, 6, 12, 18)
- Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations(Month 3, 6, 12, 18)
- The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment(Month 3, 6, 12, 18)