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

February 26, 2010
August 9, 2011
June 2001
June 2010   (final data collection date for primary outcome measure)
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.
  • Under Kaletra therapy: resistance development [ Time Frame: Baseline, week 4, 12, 24, followed by 12 weeks' intervals up to 3 years ] [ Designated as safety issue: No ]
  • Under Kaletra therapy: time to develop resistance [ Time Frame: Baseline, week 4, 12, 24, followed by 12 weeks' intervals up to 3 years ] [ Designated as safety issue: No ]
  • Under Kaletra therapy: selection of mutations and which mutations [ Time Frame: Baseline, week 4, 12, 24, followed by 12 weeks' intervals up to 3 years ] [ Designated as safety issue: No ]
  • After Kaletra failure: effectiveness of other therapy regimens [ Time Frame: Baseline, week 4, 12, 24, followed by 12 weeks' intervals up to 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01083810 on ClinicalTrials.gov Archive Site
  • 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.
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Evaluation of Kaletra Therapy Over the Long-term
Evaluation of Kaletra Therapy Over the Long-term

Long term observation of patients under lopinavir/ritonavir containing therapy

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Human Immunodeficiency Virus
Drug: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Other Names:
  • ABT-378/r
  • Kaletra
  • Lopinavir/Ritonavir
  • therapy-naive
    Patients who had not received prior antiretroviral drug therapy
    Intervention: Drug: Lopinavir/Ritonavir (Kaletra)
  • pre-treated
    Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
    Intervention: Drug: Lopinavir/Ritonavir (Kaletra)
  • non-B
    Patients infected with non-B subtypes of HIV-1
    Intervention: Drug: Lopinavir/Ritonavir (Kaletra)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01083810
KAL 1 RO
No
Dr. Stefan Simianer, Medical Director, Medical Department, Abbott Germany (Wiesbaden)
Abbott
Not Provided
Study Director: Stefan Simianer, MD Abbott Germany, Medical Department
Abbott
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP