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Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)

2011年10月10日 更新者：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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

2288

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イスラエル
      • Beer-Sheva、イスラエル、84101
        • Site Ref # / Investigator 57050
      • Haifa、イスラエル、31096
        • Site Ref # / Investigator 57048
      • Jerusalem、イスラエル、91120
        • Site Ref # / Investigator 57049
      • Kfar Saba、イスラエル、44281
        • Site Ref # / Investigator 6124
      • Rechovot、イスラエル、76100
        • Site Ref # / Investigator 57047
      • Tel-Hashomer、イスラエル
        • Site Ref # / Investigator 57051
  • ウクライナ
      • Dnepropetrovsk、ウクライナ、49115
        • Site Ref # / Investigator 57042
      • Donetsk、ウクライナ、83045
        • Site Ref # / Investigator 57043
      • Kyiv、ウクライナ、01015
        • Site Ref # / Investigator 57045
      • Kyiv、ウクライナ、01015
        • Site Ref # / Investigator 6191
      • Kyiv、ウクライナ、03115
        • Site Ref # / Investigator 57046
      • Mykolaiv、ウクライナ、54003
        • Site Ref # / Investigator 57044
      • Odessa、ウクライナ、565031
        • Site Ref # / Investigator 57039
      • Simferopol、ウクライナ、95006
        • Site Ref # / Investigator 57040
  • グルジア
      • Tbilisi、グルジア
        • Site Ref # / Investigator 7576
  • スロバキア
      • Bratislava、スロバキア、813 69
        • Site Ref # / Investigator 6208
  • スロベニア
      • Ljubljana、スロベニア、1000
        • Site Ref # / Investigator 6199
  • セルビア
      • Belgrade、セルビア、11 000
        • Site Ref # / Investigator 7579
  • チェコ共和国
      • Brno、チェコ共和国、639 00
        • Site Ref # / Investigator 57102
      • Ceske Budejovice、チェコ共和国、370 87
        • Site Ref # / Investigator 57054
      • Hradec Kralove、チェコ共和国、50005
        • Site Ref # / Investigator 57055
      • Ostrava、チェコ共和国、708 52
        • Site Ref # / Investigator 57056
      • Plzen、チェコ共和国、305 99
        • Site Ref # / Investigator 57052
      • Prague 8、チェコ共和国、180 01
        • Site Ref # / Investigator 5344
      • Usti nad Labem、チェコ共和国、40011
        • Site Ref # / Investigator 57053
  • ポーランド
      • Bialystok、ポーランド、15540
        • Site Ref # / Investigator 6190
      • Bydgoszcz、ポーランド、85-030
        • Site Ref # / Investigator 56885
      • Chorzow、ポーランド、41-500
        • Site Ref # / Investigator 56887
      • Gdansk、ポーランド、80-214
        • Site Ref # / Investigator 56883
      • Krakow、ポーランド、31-531
        • Site Ref # / Investigator 56888
      • Lodz、ポーランド、91-347
        • Site Ref # / Investigator 56889
      • Poznan、ポーランド、61-285
        • Site Ref # / Investigator 56884
      • Szczecin、ポーランド、71-455
        • Site Ref # / Investigator 56886
      • Warsaw、ポーランド、01-201
        • Site Ref # / Investigator 56882
      • Wroclaw、ポーランド、51-149
        • Site Ref # / Investigator 56890
  • ラトビア
      • Riga、ラトビア
        • Site Ref # / Investigator 7578
  • リトアニア
      • Vilnius、リトアニア、LT-10105
        • Site Ref # / Investigator 6127
  • ルーマニア
      • Brasov、ルーマニア、500174
        • Site Ref # / Investigator 57064
      • Bucharest、ルーマニア、021105
        • Site Ref # / Investigator 6194
      • Bucharest、ルーマニア、030303
        • Site Ref # / Investigator 57062
      • Constanta、ルーマニア、900708
        • Site Ref # / Investigator 57063
      • Craiova、ルーマニア、200515
        • Site Ref # / Investigator 57067
      • Iasi、ルーマニア、700116
        • Site Ref # / Investigator 57068
      • Targu Mures、ルーマニア、540394
        • Site Ref # / Investigator 57065
      • Timisoara、ルーマニア、300310
        • Site Ref # / Investigator 57066
  • ロシア連邦
      • Barnaul、ロシア連邦、658610
        • Site Ref # / Investigator 57022
      • Chelyabinsk、ロシア連邦、454052
        • Site Ref # / Investigator 56918
      • Chita、ロシア連邦、672000
        • Site Ref # / Investigator 56963
      • Ekaterinburg、ロシア連邦、620102
        • Site Ref # / Investigator 56923
      • Ekaterinburg、ロシア連邦、620115
        • Site Ref # / Investigator 56903
      • Irkutsk、ロシア連邦、664043
        • Site Ref # / Investigator 56921
      • Irkutsk、ロシア連邦、664043
        • Site Ref #/Investigator 57104
      • Ivanovo、ロシア連邦、153000
        • Site Ref # / Investigator 57028
      • Izhevsk、ロシア連邦、426067
        • Site Ref # / Investigator 57036
      • Kaliningrad、ロシア連邦、2360000
        • Site Ref # / Investigator 56945
      • Kazan、ロシア連邦、420000
        • Site Ref # / Investigator 56909
      • Kemerovo、ロシア連邦、650056
        • Site Ref # / Investigator 57037
      • Kemerovo、ロシア連邦、650056
        • Site Ref #/Investigator 57105
      • Khabarovsk、ロシア連邦、680029
        • Site Ref # / Investigator 56948
      • Khanty-Mansiysk、ロシア連邦、628002
        • Site Ref # / Investigator 56932
      • Kirov、ロシア連邦、57107
        • Site Ref #/Investigator 57107
      • Kostroma、ロシア連邦、156007
        • Site Ref # / Investigator 57030
      • Krasnodar、ロシア連邦、350015
        • Site Ref # / Investigator 56943
      • Krasnoyarsk、ロシア連邦、660049
        • Site Ref # / Investigator 56928
      • Krasnoyarsk、ロシア連邦、660049
        • Site Ref #/Investigator 57106
      • Kurgan、ロシア連邦、640007
        • Site Ref # / Investigator 57021
      • Lipetsk、ロシア連邦、398043
        • Site Ref # / Investigator 57025
      • Magnitogorsk、ロシア連邦、350015
        • Site Ref # / Investigator 56944
      • Moscow、ロシア連邦、105275
        • Site Ref # / Investigator 56904
      • Moscow、ロシア連邦、105275
        • Site Ref # / Investigator 6209
      • Moscow、ロシア連邦、129110
        • Site Ref # / Investigator 56902
      • Murmansk、ロシア連邦、183047
        • Site Ref # / Investigator 57024
      • Nizhniy Novgorod、ロシア連邦、603005
        • Site Ref # / Investigator 56907
      • Norilsk、ロシア連邦、663318
        • Site Ref # / Investigator 56964
      • Novokuznetsk、ロシア連邦、654031
        • Site Ref # / Investigator 56929
      • Novosibirsk、ロシア連邦、630000
        • Site Ref # / Investigator 56942
      • Noyabrsk、ロシア連邦、629806
        • Site Ref # / Investigator 56926
      • Orenburg、ロシア連邦、460035
        • Site Ref # / Investigator 56915
      • Orenburg、ロシア連邦、460035
        • Site Ref # / Investigator 57031
      • Perm、ロシア連邦、614000
        • Site Ref # / Investigator 56930
      • Rostov-on-Don、ロシア連邦、344006
        • Site Ref # / Investigator 56911
      • Saint Petersburg、ロシア連邦、190103
        • Site Ref # / Investigator 56906
      • Saint Petersburg、ロシア連邦、191167
        • Site Ref # / Investigator 56905
      • Samara、ロシア連邦、443041
        • Site Ref # / Investigator 56931
      • Saratov、ロシア連邦、410009
        • Site Ref # / Investigator 56913
      • St. Petersburg、ロシア連邦、190000
        • Site Ref # / Investigator 57033
      • St. Petersburg、ロシア連邦、196645
        • Site Ref # / Investigator 56920
      • St. Petersburg、ロシア連邦、196645
        • Site Ref # / Investigator 57038
      • Surgut、ロシア連邦、628400
        • Site Ref # / Investigator 56908
      • Togliatti、ロシア連邦、445846
        • Site Ref # / Investigator 56962
      • Tula、ロシア連邦、300002
        • Site Ref # / Investigator 57034
      • Tver、ロシア連邦、170024
        • Site Ref # / Investigator 56947
      • Tver、ロシア連邦、170024
        • Site Ref # / Investigator 57035
      • Tyumen、ロシア連邦、628602
        • Site Ref # / Investigator 56910
      • Tyumen、ロシア連邦、628602
        • Site Ref # / Investigator 56919
      • Ufa、ロシア連邦、450077
        • Site Ref # / Investigator 57029
      • Ulan-Ude、ロシア連邦、670034
        • Site Ref # / Investigator 56949
      • Ulyanovsk、ロシア連邦、432071
        • Site Ref # / Investigator 56914
      • Vladimir、ロシア連邦、600023
        • Site Ref # / Investigator 57027
      • Volgograd、ロシア連邦、400040
        • Site Ref # / Investigator 56916
      • Vologda、ロシア連邦、160002
        • Site Ref #/Investigator 57103
      • Yakutsk、ロシア連邦、677004
        • Site Ref # / Investigator 56946
      • Yaroslavl、ロシア連邦、150000
        • Site Ref # / Investigator 57026

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

2年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Single patients group
Single HIV-1 infected patients group

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
CD4 Count
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Reasons for Discontinuation of Lopinavir/Ritonavir
時間枠：9 months
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
9 months
Reasons for Discontinuation of Lopinavir/Ritonavir
時間枠：18 months
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
18 months
Compliance With Lopinavir/Ritonavir
時間枠：9 months
Participants reported whether they had missed doses of their antiretroviral treatment.
9 months
Compliance With Lopinavir/Ritonavir
時間枠：18 months
Participants reported whether they had missed any doses of their antiretroviral treatment.
18 months
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Abbott

捜査官

  • スタディディレクター：Maja Hojnik, MD, PhD、Abbott International

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2004年2月1日

一次修了 (実際)

2010年2月1日

研究の完了 (実際)

2010年2月1日

試験登録日

最初に提出

2011年6月22日

QC基準を満たした最初の提出物

2011年6月22日

最初の投稿 (見積もり)

2011年6月23日

学習記録の更新

投稿された最後の更新 (見積もり)

2011年10月17日

QC基準を満たした最後の更新が送信されました

2011年10月10日

最終確認日

2011年10月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • PMOS-EAST-04-1

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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