Evaluation of Kaletra Therapy Over the Long-term

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01083810
First received: February 26, 2010
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

Long term observation of patients under lopinavir/ritonavir containing therapy


Condition Intervention
Human Immunodeficiency Virus
Drug: Lopinavir/Ritonavir (Kaletra)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Kaletra Therapy Over the Long-term

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs [ Time Frame: Baseline and at any timepoint where testing is possible ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Patients With HIV-1 RNA <50 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With HIV-1 RNA >500 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Absolute CD4 Cell Count [CD4+ Cells/µL] [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 284
Study Start Date: June 2001
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
therapy-naive
Patients who had not received prior antiretroviral drug therapy
Drug: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Other Names:
  • ABT-378/r
  • Kaletra
  • Lopinavir/Ritonavir
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
Drug: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Other Names:
  • ABT-378/r
  • Kaletra
  • Lopinavir/Ritonavir
non-B
Patients infected with non-B subtypes of HIV-1
Drug: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Other Names:
  • ABT-378/r
  • Kaletra
  • Lopinavir/Ritonavir

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083810

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

No publications provided

Responsible Party: Dr. Stefan Simianer, Medical Director, Medical Department, Abbott Germany (Wiesbaden)
ClinicalTrials.gov Identifier: NCT01083810     History of Changes
Obsolete Identifiers: NCT01081470, NCT01083836
Other Study ID Numbers: KAL 1 RO
Study First Received: February 26, 2010
Results First Received: June 30, 2011
Last Updated: August 9, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:
Human Immunodeficiency Virus
Infection
Kaletra
Resistance
Mutations
alternative Therapy regimen

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014