이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Evaluation of Kaletra Therapy Over the Long-term

2011년 8월 9일 업데이트: Abbott
Long term observation of patients under lopinavir/ritonavir containing therapy

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks).

These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

연구 유형

관찰

등록 (실제)

284

연락처 및 위치

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

연구 장소

  • 독일
      • Aachen, 독일, 52062
        • Site Ref # / Investigator 27706
      • Aachen, 독일, 52062
        • Site Ref # / Investigator 52972
      • Berlin, 독일, 10117
        • Site Ref # / Investigator 27660
      • Berlin, 독일, 10117
        • Site Ref # / Investigator 27937
      • Berlin, 독일, 10117
        • Site Ref # / Investigator 52973
      • Berlin, 독일, 10243
        • Site Reference ID/Investigator# 27629
      • Berlin, 독일, 10439
        • Site Ref # / Investigator 27651
      • Berlin, 독일, 10439
        • Site Ref # / Investigator 27912
      • Berlin, 독일, 10439
        • Site Reference ID/Investigator# 27544
      • Berlin, 독일, 10551
        • Site Reference ID/Investigator# 27567
      • Berlin, 독일, 10589
        • Site Ref # / Investigator 27929
      • Berlin, 독일, 10707
        • Site Ref # / Investigator 52971
      • Berlin, 독일, 10707
        • Site Ref # / Investigator 53468
      • Berlin, 독일, 10777
        • Site Ref # / Investigator 27965
      • Berlin, 독일, 10777
        • Site Reference ID/Investigator# 27547
      • Berlin, 독일, 10777
        • Site Reference ID/Investigator# 27552
      • Berlin, 독일, 10777
        • Site Reference ID/Investigator# 27562
      • Berlin, 독일, 10961
        • Site Ref # / Investigator 52984
      • Berlin, 독일, 13347
        • Site Ref # / Investigator 27639
      • Berlin, 독일, 13347
        • Site Ref # / Investigator 52970
      • Berlin, 독일, D-10243
        • Site Ref # / Investigator 27909
      • Berlin, 독일, D-10243
        • Site Ref # / Investigator 47113
      • Chemnitz, 독일, 09113
        • Site Reference ID/Investigator# 27574
      • Cologne, 독일, 50674
        • Site Ref # / Investigator 28060
      • Cologne, 독일, 50674
        • Site Ref # / Investigator 52978
      • Cologne, 독일, 50679
        • Site Ref # / Investigator 27932
      • Cologne, 독일, 50679
        • Site Ref # / Investigator 52979
      • Cologne, 독일, 50931
        • Site Ref # / Investigator 48233
      • Cologne, 독일, 50931
        • Site Ref # / Investigator 52985
      • Cologne, 독일, 50931
        • Site Ref # / Investigator 53464
      • Dortmund, 독일, 44137
        • Site Ref # / Investigator 27704
      • Dortmund, 독일, 44137
        • Site Ref # / Investigator 27947
      • Dortmund, 독일, 44137
        • Site Ref # / Investigator 52968
      • Duesseldorf, 독일, 40237
        • Site Ref # / Investigator 28056
      • Duisburg, 독일, 47259
        • Site Reference ID/Investigator# 27558
      • Frankfurt, 독일, 15232
        • Site Ref # / Investigator 52983
      • Frankfurt, 독일, 60311
        • Site Ref # / Investigator 27928
      • Frankfurt, 독일, 60311
        • Site Ref # / Investigator 52967
      • Freiburg, 독일, 79106
        • Site Reference ID/Investigator# 27565
      • Fuerth, 독일, 90762
        • Site Reference ID/Investigator# 27566
      • Fuerth, 독일, D-90762
        • Site Ref # / Investigator 53465
      • Hamburg, 독일, 20099
        • Site Ref # / Investigator 27931
      • Hamburg, 독일, 20099
        • Site Ref # / Investigator 27982
      • Hamburg, 독일, 20099
        • Site Ref # / Investigator 47114
      • Hamburg, 독일, 20099
        • Site Ref # / Investigator 47115
      • Hamburg, 독일, 20099
        • Site Reference ID/Investigator# 27551
      • Hamburg, 독일, 20099
        • Site Reference ID/Investigator# 27634
      • Hamburg, 독일, 20146
        • Site Ref # / Investigator 30864
      • Hamburg, 독일, 20146
        • Site Ref # / Investigator 5348
      • Hamburg, 독일, 20146
        • Site Reference ID/Investigator# 27546
      • Hamburg, 독일, 20246
        • Site Ref # / Investigator 28032
      • Hamburg, 독일, 20246
        • Site Ref # / Investigator 52969
      • Hamburg, 독일, 20246
        • Site Ref # / Investigator 53467
      • Hamburg, 독일, 20354
        • Site Ref # / Investigator 52980
      • Karlsruhe, 독일, 76135
        • Site Ref # / Investigator 27641
      • Karlsruhe, 독일, 76135
        • Site Ref # / Investigator 27964
      • Karlsruhe, 독일, 76135
        • Site Reference ID/Investigator# 27561
      • Koblenz, 독일, 56065
        • Site Ref # / Investigator 53466
      • Koblenz, 독일, 56065
        • Site Reference ID/Investigator# 27555
      • Krefeld, 독일, 47800
        • Site Ref # / Investigator 27905
      • Leipzig, 독일, 04107
        • Site Ref # / Investigator 27906
      • Leipzig, 독일, 04107
        • Site Ref # / Investigator 52975
      • Leipzig, 독일, 04107
        • Site Ref # / Investigator 53463
      • Ludwigshafen, 독일, 67063
        • Site Ref # / Investigator 27948
      • Ludwigshafen, 독일, 67063
        • Site Ref # / Investigator 52977
      • Mainz, 독일, 55116
        • Site Ref # / Investigator 27902
      • Mainz, 독일, 55116
        • Site Reference ID/Investigator# 27543
      • Moenchengladbach, 독일, 41061
        • Site Ref # / Investigator 28104
      • Moenchengladbach, 독일, 41061
        • Site Ref # / Investigator 52981
      • Muenster, 독일, 48149
        • Site Ref # / Investigator 27648
      • Muenster, 독일, 48149
        • Site Reference ID/Investigator# 27568
      • Munich, 독일, 80337
        • Site Ref # / Investigator 27949
      • Munich, 독일, 80337
        • Site Reference ID/Investigator# 27553
      • Munich, 독일, 80801
        • Site Ref # / Investigator 27926
      • Munich, 독일, 80801
        • Site Ref # / Investigator 53462
      • Nuernberg, 독일, 90419
        • Site Ref # / Investigator 52982
      • Oldenburg, 독일, 26121
        • Site Ref # / Investigator 27988
      • Oldenburg, 독일, 26121
        • Site Reference ID/Investigator# 27563
      • Osnabrueck, 독일, 49076
        • Site Ref # / Investigator 27637
      • Osnabrueck, 독일, 49076
        • Site Ref # / Investigator 27943
      • Osnabrueck, 독일, 49076
        • Site Ref # / Investigator 52974
      • Paderborn, 독일, 33100
        • Site Ref # / Investigator 27939
      • Rostock, 독일, 18057
        • Site Ref # / Investigator 27649
      • Rostock, 독일, D-18057
        • Site Reference ID/Investigator# 27569
      • Stuttgart, 독일, 70197
        • Site Ref # / Investigator 27647
      • Stuttgart, 독일, 70197
        • Site Ref # / Investigator 28047
      • Stuttgart, 독일, 70197
        • Site Ref # / Investigator 28048
      • Stuttgart, 독일, 70197
        • Site Reference ID/Investigator# 27631
      • Troisdorf, 독일, 53840
        • Site Ref # / Investigator 52976
      • Wuppertal, 독일, 42277
        • Site Ref # / Investigator 27961

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Human Immunodeficiency Virus-infected, protease inhibitor-naïve patients from a clinical setting

설명

Inclusion Criteria:

  • Patients infected by HIV-1
  • Age greater than or equal to 18 years

Exclusion Criteria:

  • as described in SmPC (summary of product characteristics) at the time of prescription

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
개입 / 치료
therapy-naive
Patients who had not received prior antiretroviral drug therapy
의약품: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
다른 이름들:
  • 칼레트라
  • 로피나비르/리토나비르
  • ABT-378/r
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
의약품: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
다른 이름들:
  • 칼레트라
  • 로피나비르/리토나비르
  • ABT-378/r
non-B
Patients infected with non-B subtypes of HIV-1
의약품: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
다른 이름들:
  • 칼레트라
  • 로피나비르/리토나비르
  • ABT-378/r

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
기간: Baseline and at any timepoint where testing is possible
Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.
Baseline and at any timepoint where testing is possible

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Patients With HIV-1 RNA <50 Copies/ml
기간: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
기간: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
기간: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA >500 Copies/ml
기간: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
기간: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
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. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Abbott

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

2001년 6월 1일

기본 완료 (실제)

2010년 6월 1일

연구 완료 (실제)

2010년 6월 1일

연구 등록 날짜

최초 제출

2010년 2월 26일

QC 기준을 충족하는 최초 제출

2010년 3월 8일

처음 게시됨 (추정)

2010년 3월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 8월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 8월 9일

마지막으로 확인됨

2011년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KAL 1 RO

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. .

구독하다