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Evaluation of Kaletra Therapy Over the Long-term

9 de agosto de 2011 actualizado por: Abbott
Long term observation of patients under lopinavir/ritonavir containing therapy

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

284

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
therapy-naive
Patients who had not received prior antiretroviral drug therapy
Droga: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Otros nombres:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
Droga: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Otros nombres:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r
non-B
Patients infected with non-B subtypes of HIV-1
Droga: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Otros nombres:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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]
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Abbott

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2001

Finalización primaria (Actual)

1 de junio de 2010

Finalización del estudio (Actual)

1 de junio de 2010

Fechas de registro del estudio

Enviado por primera vez

26 de febrero de 2010

Primero enviado que cumplió con los criterios de control de calidad

8 de marzo de 2010

Publicado por primera vez (Estimar)

10 de marzo de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de agosto de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

9 de agosto de 2011

Última verificación

1 de agosto de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KAL 1 RO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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