Kaletra: Therapy With Double Protease Inhibitors
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01075191
First received: February 23, 2010
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants
| Condition |
|---|
|
Human Immunodeficiency Virus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | PMOS: Kaletra Double Protease Inhibitors |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 65 |
| Study Start Date: | January 2004 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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). |
Detailed Description:
This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Community sample; Human Immunodeficiency Virus-infected participants
Criteria
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
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: NCT01075191
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075191
Locations
| 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 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Stefan Simianer, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department |
More Information
Additional Information:
| Responsible Party: | AbbVie (prior sponsor, Abbott) |
| ClinicalTrials.gov Identifier: | NCT01075191 History of Changes |
| Other Study ID Numbers: | P05-103 |
| Study First Received: | February 23, 2010 |
| Results First Received: | September 28, 2012 |
| Last Updated: | January 14, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AbbVie:
|
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 Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 23, 2016