Kaletra: Therapy With Double Protease Inhibitors
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ClinicalTrials.gov Identifier: NCT01075191 |
Recruitment Status
:
Completed
First Posted
: February 25, 2010
Results First Posted
: October 30, 2012
Last Update Posted
: January 18, 2013
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Condition or disease |
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Human Immunodeficiency Virus |
Study Type : | Observational |
Actual Enrollment : | 65 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | PMOS: Kaletra Double Protease Inhibitors |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Group/Cohort |
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HIV-infected participants
HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily). |
- Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.
- Change From Baseline in Absolute CD4 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
- Change From Baseline in Relative CD4 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.
- Change From Baseline in Absolute CD8 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.
- Change From Baseline in Relative CD8 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.
- Change From Baseline in CD4/CD8 T-cell Ratio [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Participants with Human Immunodeficiency Virus infection
- Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor
Exclusion Criteria:
- Hypersensitivity against lopinavir, ritonavir or other ingredients
- Severe liver insufficiency
- No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075191
Germany | |
Site Reference ID/Investigator# 48283 | |
Berlin, Germany, 10439 | |
Site Reference ID/Investigator# 28131 | |
Berlin, Germany, 10551 | |
Site Reference ID/Investigator# 66422 | |
Berlin, Germany, 10961 | |
Site Reference ID/Investigator# 28123 | |
Berlin, Germany, 13347 | |
Site Reference ID/Investigator# 28109 | |
Berlin, Germany, D-10243 | |
Site Reference ID/Investigator# 28115 | |
Dortmund, Germany, 44137 | |
Site Reference ID/Investigator# 28124 | |
Frankfurt, Germany, 60311 | |
Site Reference ID/Investigator# 28127 | |
Frankfurt, Germany, 60329 | |
Site Reference ID/Investigator# 28119 | |
Frankfurt, Germany, 60596 | |
Site Reference ID/Investigator# 5318 | |
Krefeld, Germany, 47800 | |
Site Reference ID/Investigator# 28112 | |
Ludwigshafen, Germany, 67063 | |
Site Reference ID/Investigator# 28111 | |
Muenster, Germany, 48143 | |
Site Reference ID/Investigator# 28129 | |
Muenster, Germany, 48149 | |
Site Reference ID/Investigator# 28118 | |
Munich, Germany, 80337 | |
Site Reference ID/Investigator# 28113 | |
Munich, Germany, 80801 | |
Site Reference ID/Investigator# 28133 | |
Stuttgart, Germany, 70197 | |
Site Reference ID/Investigator# 28126 | |
Wuppertal, Germany, 42277 |
Study Director: | Stefan Simianer, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department |
Additional Information:
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT01075191 History of Changes |
Other Study ID Numbers: |
P05-103 |
First Posted: | February 25, 2010 Key Record Dates |
Results First Posted: | October 30, 2012 |
Last Update Posted: | January 18, 2013 |
Last Verified: | January 2013 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Viral load Resistance Double protease inhibitors Mutations |
Immune system Infection Nucleoside Reverse Transcriptase Inhibitors-free Human Immunodeficiency Virus |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Protease Inhibitors Lopinavir HIV Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |