Kaletra: Therapy With Double Protease Inhibitors

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT01075191
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-25
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2012-09-28
• Results First Submitted QC: 2012-09-28
• Results First Posted: 2012-10-30
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Absolute CD8 Cell Count	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 CD4/CD8 T-cell Ratio	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.
Change From Baseline in Relative CD4 Cell Count	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 Relative CD8 Cell Count	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 Absolute CD4 Cell Count	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.

Trial Locations

Locations (17)

Site Reference ID/Investigator# 28115; 🇩🇪 Dortmund, Germany

Site Reference ID/Investigator# 48283; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 28131; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 66422; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 28123; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 28127; 🇩🇪 Frankfurt, Germany

Site Reference ID/Investigator# 28124; 🇩🇪 Frankfurt, Germany

Site Reference ID/Investigator# 28109; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 28119; 🇩🇪 Frankfurt, Germany

Site Reference ID/Investigator# 28112; 🇩🇪 Ludwigshafen, Germany

Site Reference ID/Investigator# 5318; 🇩🇪 Krefeld, Germany

Site Reference ID/Investigator# 28129; 🇩🇪 Muenster, Germany

Site Reference ID/Investigator# 28111; 🇩🇪 Muenster, Germany

Site Reference ID/Investigator# 28118; 🇩🇪 Munich, Germany

Site Reference ID/Investigator# 28113; 🇩🇪 Munich, Germany

Site Reference ID/Investigator# 28126; 🇩🇪 Wuppertal, Germany

Site Reference ID/Investigator# 28133; 🇩🇪 Stuttgart, Germany