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Evaluation of Kaletra Therapy Over the Long-term

9 augusti 2011 uppdaterad av: Abbott
Long term observation of patients under lopinavir/ritonavir containing therapy

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

284

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
therapy-naive
Patients who had not received prior antiretroviral drug therapy
Läkemedel: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Andra namn:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
Läkemedel: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Andra namn:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r
non-B
Patients infected with non-B subtypes of HIV-1
Läkemedel: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Andra namn:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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]
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Abbott

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2001

Primärt slutförande (Faktisk)

1 juni 2010

Avslutad studie (Faktisk)

1 juni 2010

Studieregistreringsdatum

Först inskickad

26 februari 2010

Först inskickad som uppfyllde QC-kriterierna

8 mars 2010

Första postat (Uppskatta)

10 mars 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 augusti 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 augusti 2011

Senast verifierad

1 augusti 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KAL 1 RO

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