Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)
2011년 10월 10일 업데이트: Abbott
KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients.
The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries.
The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.
연구 개요
상태
완전한
상세 설명
As this study is observational in nature, subject follow-up was not specified by the protocol but was left to the judgment of each physician within the 18 months period, which defines the survey for each participant.
For indicative purposes, follow-up of each participant should enable approximately 7 visits during this period.
These visits will take place at average intervals of 3 months, apart from the first visit following inclusion (usually at the end of the first treatment month) and apart from visits required because of intercurrent events.
Participant visits were assigned as follows: Baseline/Day 0 (start of lopinavir/ritonavir treatment), Month 1 (day 1 to day 45), Month 3 (day 46 to day 136), Month 6 (day 137 to day 228), Month 9 (day 229 to day 319), Month 12 (day 320 to day 410), Month 15 (day 411 to day 501), Month 18 (day 502 to day 593).
Each participant is planned to be observed during his/her lopinavir/ritonavir capsule containing treatment regimen for a maximum period of 18 months, and each participant is planned to be observed during his/her lopinavir/ritonavir tablet containing treatment regimen for a maximum period of 9 months.
연구 유형
관찰
등록 (실제)
2288
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Tbilisi, 그루지야
- Site Ref # / Investigator 7576
-
-
-
-
-
Riga, 라트비아
- Site Ref # / Investigator 7578
-
-
-
-
-
Barnaul, 러시아 연방, 658610
- Site Ref # / Investigator 57022
-
Chelyabinsk, 러시아 연방, 454052
- Site Ref # / Investigator 56918
-
Chita, 러시아 연방, 672000
- Site Ref # / Investigator 56963
-
Ekaterinburg, 러시아 연방, 620102
- Site Ref # / Investigator 56923
-
Ekaterinburg, 러시아 연방, 620115
- Site Ref # / Investigator 56903
-
Irkutsk, 러시아 연방, 664043
- Site Ref # / Investigator 56921
-
Irkutsk, 러시아 연방, 664043
- Site Ref #/Investigator 57104
-
Ivanovo, 러시아 연방, 153000
- Site Ref # / Investigator 57028
-
Izhevsk, 러시아 연방, 426067
- Site Ref # / Investigator 57036
-
Kaliningrad, 러시아 연방, 2360000
- Site Ref # / Investigator 56945
-
Kazan, 러시아 연방, 420000
- Site Ref # / Investigator 56909
-
Kemerovo, 러시아 연방, 650056
- Site Ref # / Investigator 57037
-
Kemerovo, 러시아 연방, 650056
- Site Ref #/Investigator 57105
-
Khabarovsk, 러시아 연방, 680029
- Site Ref # / Investigator 56948
-
Khanty-Mansiysk, 러시아 연방, 628002
- Site Ref # / Investigator 56932
-
Kirov, 러시아 연방, 57107
- Site Ref #/Investigator 57107
-
Kostroma, 러시아 연방, 156007
- Site Ref # / Investigator 57030
-
Krasnodar, 러시아 연방, 350015
- Site Ref # / Investigator 56943
-
Krasnoyarsk, 러시아 연방, 660049
- Site Ref # / Investigator 56928
-
Krasnoyarsk, 러시아 연방, 660049
- Site Ref #/Investigator 57106
-
Kurgan, 러시아 연방, 640007
- Site Ref # / Investigator 57021
-
Lipetsk, 러시아 연방, 398043
- Site Ref # / Investigator 57025
-
Magnitogorsk, 러시아 연방, 350015
- Site Ref # / Investigator 56944
-
Moscow, 러시아 연방, 105275
- Site Ref # / Investigator 56904
-
Moscow, 러시아 연방, 105275
- Site Ref # / Investigator 6209
-
Moscow, 러시아 연방, 129110
- Site Ref # / Investigator 56902
-
Murmansk, 러시아 연방, 183047
- Site Ref # / Investigator 57024
-
Nizhniy Novgorod, 러시아 연방, 603005
- Site Ref # / Investigator 56907
-
Norilsk, 러시아 연방, 663318
- Site Ref # / Investigator 56964
-
Novokuznetsk, 러시아 연방, 654031
- Site Ref # / Investigator 56929
-
Novosibirsk, 러시아 연방, 630000
- Site Ref # / Investigator 56942
-
Noyabrsk, 러시아 연방, 629806
- Site Ref # / Investigator 56926
-
Orenburg, 러시아 연방, 460035
- Site Ref # / Investigator 56915
-
Orenburg, 러시아 연방, 460035
- Site Ref # / Investigator 57031
-
Perm, 러시아 연방, 614000
- Site Ref # / Investigator 56930
-
Rostov-on-Don, 러시아 연방, 344006
- Site Ref # / Investigator 56911
-
Saint Petersburg, 러시아 연방, 190103
- Site Ref # / Investigator 56906
-
Saint Petersburg, 러시아 연방, 191167
- Site Ref # / Investigator 56905
-
Samara, 러시아 연방, 443041
- Site Ref # / Investigator 56931
-
Saratov, 러시아 연방, 410009
- Site Ref # / Investigator 56913
-
St. Petersburg, 러시아 연방, 190000
- Site Ref # / Investigator 57033
-
St. Petersburg, 러시아 연방, 196645
- Site Ref # / Investigator 56920
-
St. Petersburg, 러시아 연방, 196645
- Site Ref # / Investigator 57038
-
Surgut, 러시아 연방, 628400
- Site Ref # / Investigator 56908
-
Togliatti, 러시아 연방, 445846
- Site Ref # / Investigator 56962
-
Tula, 러시아 연방, 300002
- Site Ref # / Investigator 57034
-
Tver, 러시아 연방, 170024
- Site Ref # / Investigator 56947
-
Tver, 러시아 연방, 170024
- Site Ref # / Investigator 57035
-
Tyumen, 러시아 연방, 628602
- Site Ref # / Investigator 56910
-
Tyumen, 러시아 연방, 628602
- Site Ref # / Investigator 56919
-
Ufa, 러시아 연방, 450077
- Site Ref # / Investigator 57029
-
Ulan-Ude, 러시아 연방, 670034
- Site Ref # / Investigator 56949
-
Ulyanovsk, 러시아 연방, 432071
- Site Ref # / Investigator 56914
-
Vladimir, 러시아 연방, 600023
- Site Ref # / Investigator 57027
-
Volgograd, 러시아 연방, 400040
- Site Ref # / Investigator 56916
-
Vologda, 러시아 연방, 160002
- Site Ref #/Investigator 57103
-
Yakutsk, 러시아 연방, 677004
- Site Ref # / Investigator 56946
-
Yaroslavl, 러시아 연방, 150000
- Site Ref # / Investigator 57026
-
-
-
-
-
Brasov, 루마니아, 500174
- Site Ref # / Investigator 57064
-
Bucharest, 루마니아, 021105
- Site Ref # / Investigator 6194
-
Bucharest, 루마니아, 030303
- Site Ref # / Investigator 57062
-
Constanta, 루마니아, 900708
- Site Ref # / Investigator 57063
-
Craiova, 루마니아, 200515
- Site Ref # / Investigator 57067
-
Iasi, 루마니아, 700116
- Site Ref # / Investigator 57068
-
Targu Mures, 루마니아, 540394
- Site Ref # / Investigator 57065
-
Timisoara, 루마니아, 300310
- Site Ref # / Investigator 57066
-
-
-
-
-
Vilnius, 리투아니아, LT-10105
- Site Ref # / Investigator 6127
-
-
-
-
-
Belgrade, 세르비아, 11 000
- Site Ref # / Investigator 7579
-
-
-
-
-
Bratislava, 슬로바키아, 813 69
- Site Ref # / Investigator 6208
-
-
-
-
-
Ljubljana, 슬로베니아, 1000
- Site Ref # / Investigator 6199
-
-
-
-
-
Dnepropetrovsk, 우크라이나, 49115
- Site Ref # / Investigator 57042
-
Donetsk, 우크라이나, 83045
- Site Ref # / Investigator 57043
-
Kyiv, 우크라이나, 01015
- Site Ref # / Investigator 57045
-
Kyiv, 우크라이나, 01015
- Site Ref # / Investigator 6191
-
Kyiv, 우크라이나, 03115
- Site Ref # / Investigator 57046
-
Mykolaiv, 우크라이나, 54003
- Site Ref # / Investigator 57044
-
Odessa, 우크라이나, 565031
- Site Ref # / Investigator 57039
-
Simferopol, 우크라이나, 95006
- Site Ref # / Investigator 57040
-
-
-
-
-
Beer-Sheva, 이스라엘, 84101
- Site Ref # / Investigator 57050
-
Haifa, 이스라엘, 31096
- Site Ref # / Investigator 57048
-
Jerusalem, 이스라엘, 91120
- Site Ref # / Investigator 57049
-
Kfar Saba, 이스라엘, 44281
- Site Ref # / Investigator 6124
-
Rechovot, 이스라엘, 76100
- Site Ref # / Investigator 57047
-
Tel-Hashomer, 이스라엘
- Site Ref # / Investigator 57051
-
-
-
-
-
Brno, 체코 공화국, 639 00
- Site Ref # / Investigator 57102
-
Ceske Budejovice, 체코 공화국, 370 87
- Site Ref # / Investigator 57054
-
Hradec Kralove, 체코 공화국, 50005
- Site Ref # / Investigator 57055
-
Ostrava, 체코 공화국, 708 52
- Site Ref # / Investigator 57056
-
Plzen, 체코 공화국, 305 99
- Site Ref # / Investigator 57052
-
Prague 8, 체코 공화국, 180 01
- Site Ref # / Investigator 5344
-
Usti nad Labem, 체코 공화국, 40011
- Site Ref # / Investigator 57053
-
-
-
-
-
Bialystok, 폴란드, 15540
- Site Ref # / Investigator 6190
-
Bydgoszcz, 폴란드, 85-030
- Site Ref # / Investigator 56885
-
Chorzow, 폴란드, 41-500
- Site Ref # / Investigator 56887
-
Gdansk, 폴란드, 80-214
- Site Ref # / Investigator 56883
-
Krakow, 폴란드, 31-531
- Site Ref # / Investigator 56888
-
Lodz, 폴란드, 91-347
- Site Ref # / Investigator 56889
-
Poznan, 폴란드, 61-285
- Site Ref # / Investigator 56884
-
Szczecin, 폴란드, 71-455
- Site Ref # / Investigator 56886
-
Warsaw, 폴란드, 01-201
- Site Ref # / Investigator 56882
-
Wroclaw, 폴란드, 51-149
- Site Ref # / Investigator 56890
-
-
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
2년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
KaleEAST is non-interventional, observational study in which Kaletra® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regard to dose, population and indication.
설명
Inclusion Criteria:
Patients infected by HIV-1 infection who are either:
- Antiretroviral treatment (ART) naive or
- Had failed or had been intolerant to one previous combined antiretroviral treatment (cART), not including a Protease inhibitor (PI) (first-line pretreated without a Protease inhibitor) or
- Had failed or had been intolerant to one previous antiretroviral treatment ART, including one Protease inhibitor (first-line pretreated with a Protease Inhibitor).
A ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.
Exclusion Criteria:
- Treatment with drugs at risk for interactions with lopinavir/ritonavir
- Uncontrolled AIDS defining disease
- Two or more previous Protease inhibitors (PIs)
- Participation in another study or clinical trial
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Single patients group
Single HIV-1 infected patients group
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
CD4 Count
기간: Baseline
|
CD4 lymphocyte count is a measure of a participant's immunologic health.
Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.
|
Baseline
|
|
Changes in CD4 Count
기간: Baseline to 1 month
|
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
|
Baseline to 1 month
|
|
Changes in CD4 Count
기간: Baseline to 3 months
|
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
|
Baseline to 3 months
|
|
Changes in CD4 Count
기간: Baseline to 6 months
|
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
|
Baseline to 6 months
|
|
Changes in CD4 Count
기간: Baseline to 9 months
|
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
|
Baseline to 9 months
|
|
Changes in CD4 Count
기간: Baseline to 12 months
|
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
|
Baseline to 12 months
|
|
Changes in CD4 Count
기간: Baseline to 15 months
|
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
|
Baseline to 15 months
|
|
Changes in CD4 Count
기간: Baseline to 18 months
|
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
|
Baseline to 18 months
|
|
Viral Load
기간: Baseline
|
Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma).
The number of HIV-RNA copies in the blood was measured at baseline.
|
Baseline
|
|
Viral Load
기간: 1 month
|
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits.
A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
|
1 month
|
|
Viral Load
기간: 3 months
|
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits.
A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
|
3 months
|
|
Viral Load
기간: 6 months
|
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits.
A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
|
6 months
|
|
Viral Load
기간: 9 months
|
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits.
A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
|
9 months
|
|
Viral Load
기간: 12 months
|
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits.
A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
|
12 months
|
|
Viral Load
기간: 15 months
|
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits.
A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
|
15 months
|
|
Viral Load
기간: 18 months
|
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits.
A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
|
18 months
|
|
Laboratory Parameter Blood Glucose
기간: Baseline, 9 months, 18 months
|
Blood glucose laboratory values were assessed at baseline and scheduled study visits.
Normal ranges are based on the standards for individual facilities in each country.
|
Baseline, 9 months, 18 months
|
|
Laboratory Parameter Transaminases
기간: Baseline, 9 months, 18 months
|
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits.
Normal ranges are based on the standards for individual facilities in each country.
|
Baseline, 9 months, 18 months
|
|
Laboratory Parameter Lipids
기간: Baseline, 9 months, 18 months
|
A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits.
Normal ranges are based on the standards for individual facilities in each country.
|
Baseline, 9 months, 18 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Reasons for Discontinuation of Lopinavir/Ritonavir
기간: 9 months
|
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
|
9 months
|
|
Reasons for Discontinuation of Lopinavir/Ritonavir
기간: 18 months
|
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
|
18 months
|
|
Compliance With Lopinavir/Ritonavir
기간: 9 months
|
Participants reported whether they had missed doses of their antiretroviral treatment.
|
9 months
|
|
Compliance With Lopinavir/Ritonavir
기간: 18 months
|
Participants reported whether they had missed any doses of their antiretroviral treatment.
|
18 months
|
|
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
기간: 18 months
|
Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment. All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the "Reported Adverse Events" section of this record. |
18 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Maja Hojnik, MD, PhD, Abbott International
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
2004년 2월 1일
기본 완료 (실제)
2010년 2월 1일
연구 완료 (실제)
2010년 2월 1일
연구 등록 날짜
최초 제출
2011년 6월 22일
QC 기준을 충족하는 최초 제출
2011년 6월 22일
처음 게시됨 (추정)
2011년 6월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 10월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 10월 10일
마지막으로 확인됨
2011년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PMOS-EAST-04-1
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. .