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Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection

2014년 12월 12일 업데이트: AbbVie (prior sponsor, Abbott)

Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection

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)

연구 개요

상태

완전한

정황

인간 면역결핍 바이러스 감염

연구 유형

관찰

등록 (실제)

236

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

일본
- - Fukuoka-shi, 일본
    - Site Reference ID/Investigator# 57629
  - Hiroshima-shi, 일본
    - Site Reference ID/Investigator# 57630
  - Hokkaido, 일본
    - Site Reference ID/Investigator# 57631
  - Kitakyushu-shi, 일본
    - Site Reference ID/Investigator# 57628
  - Kurashiki-shi, 일본
    - Site Reference ID/Investigator# 57638
  - Kyoto, 일본
    - Site Reference ID/Investigator# 57634
  - Nagoya-shi, 일본
    - Site Reference ID/Investigator# 57625
  - Nagoya-shi, 일본
    - Site Reference ID/Investigator# 57626
  - Niigata, 일본
    - Site Reference ID/Investigator# 57637
  - Nishinomiya-shi, 일본
    - Site Reference ID/Investigator# 57632
  - Osaka, 일본
    - Site Reference ID/Investigator# 57640
  - Osaka-shi, 일본
    - Site Reference ID/Investigator# 57639
  - Sendai-shi, 일본
    - Site Reference ID/Investigator# 57636
  - Tokyo, 일본
    - Site Reference ID/Investigator# 48722
  - Tokyo, 일본
    - Site Reference ID/Investigator# 57641
  - Tokyo, 일본
    - Site Reference ID/Investigator# 57643
  - Tokyo, 일본
    - Site Reference ID/Investigator# 57644
  - Tokyo, 일본
    - Site Reference ID/Investigator# 57645
  - Tokyo, 일본
    - Site Reference ID/Investigator# 57646
  - Tokyo, 일본
    - Site Reference ID/Investigator# 57647
  - Tokyo, 일본
    - Site Reference ID/Investigator# 57648
  - Tokyo, 일본
    - Site Reference ID/Investigator# 57650
  - Yokohama-shi, 일본
    - Site Reference ID/Investigator# 57633

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label

설명

Inclusion Criteria:

- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.

Exclusion Criteria:

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
Lopinavir/Ritonavir Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Percentage of Participants With Adverse Drug Reactions 기간: 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".	Up to 60 Months
Number of Adverse Drug Reactions 기간: 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".	Up to 60 Months

2차 결과 측정

결과 측정	측정값 설명	기간
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	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 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	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 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown". Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs 기간: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Serious Adverse Events 기간: Up to 60 Months	A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.	Up to 60 Months
Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation 기간: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir		Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation 기간: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir		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 기간: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir	For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.	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 기간: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir	For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.	Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Number of Participants in Each CDC Classification Category of HIV-infection Over Time 기간: Up to Month 60 after first dose of Lopinavir/Ritonavir	CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.	Up to Month 60 after first dose of Lopinavir/Ritonavir
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants 기간: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir	Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.	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 기간: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir	Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.	Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AbbVie (prior sponsor, Abbott)

수사관

연구 책임자: Susumu Adachi, MD, AbbVie G.K.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

Related Info

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 6월 1일

기본 완료 (실제)

2013년 12월 1일

연구 완료 (실제)

2013년 12월 1일

연구 등록 날짜

최초 제출

2011년 4월 1일

QC 기준을 충족하는 최초 제출

2011년 4월 1일

처음 게시됨 (추정)

2011년 4월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 12월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 12월 12일

마지막으로 확인됨

2014년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection

추가 관련 MeSH 약관

기타 연구 ID 번호

P12-760

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .