NCT01328158已完成不适用
Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection
AbbVie (prior sponsor, Abbott)23 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2011年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 23
- 主要终点
- Percentage of Participants With Adverse Drug Reactions
研究概览
简要总结
This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Kaletra (QD)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.
排除标准
- •Participants with a history of hypersensitivity to any ingredient of this drug.
- •Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.
结局指标
主要结局
Percentage of Participants With Adverse Drug Reactions
时间窗: Up to 60 Months
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Number of Adverse Drug Reactions
时间窗: Up to 60 Months
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
次要结局
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia(Up to 60 Months)
- Number of Participants With Serious Adverse Events(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs(Up to 60 Months)
- Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation(Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir)
- Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation(Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir(Up to 60 Months)
- Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation(Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir)
- Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation(Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir)
- Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants(Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir)
- Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants(Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs(Up to 60 Months)
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs(Up to 60 Months)
- Number of Participants in Each CDC Classification Category of HIV-infection Over Time(Up to Month 60 after first dose of Lopinavir/Ritonavir)
研究者
研究点 (23)
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