Kaletra: Therapy With Double Protease Inhibitors

Human Immunodeficiency Virus Clinical Trial

Official title:

PMOS: Kaletra Double Protease Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075191
• Other study ID #: P05-103
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: January 14, 2013
• Start date: January 2004
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
Germany	Site Reference ID/Investigator# 28109	Berlin
Germany	Site Reference ID/Investigator# 28123	Berlin
Germany	Site Reference ID/Investigator# 28131	Berlin
Germany	Site Reference ID/Investigator# 48283	Berlin
Germany	Site Reference ID/Investigator# 66422	Berlin
Germany	Site Reference ID/Investigator# 28115	Dortmund
Germany	Site Reference ID/Investigator# 28119	Frankfurt
Germany	Site Reference ID/Investigator# 28124	Frankfurt
Germany	Site Reference ID/Investigator# 28127	Frankfurt
Germany	Site Reference ID/Investigator# 5318	Krefeld
Germany	Site Reference ID/Investigator# 28112	Ludwigshafen
Germany	Site Reference ID/Investigator# 28111	Muenster
Germany	Site Reference ID/Investigator# 28129	Muenster
Germany	Site Reference ID/Investigator# 28113	Munich
Germany	Site Reference ID/Investigator# 28118	Munich
Germany	Site Reference ID/Investigator# 28133	Stuttgart
Germany	Site Reference ID/Investigator# 28126	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL	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.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144	No
Secondary	Change From Baseline in Absolute CD4 Cell Count	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.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144	No
Secondary	Change From Baseline in Relative CD4 Cell Count	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.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144	No
Secondary	Change From Baseline in Absolute CD8 Cell Count	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.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144	No
Secondary	Change From Baseline in Relative CD8 Cell Count	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.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144	No
Secondary	Change From Baseline in CD4/CD8 T-cell Ratio	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.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144	No

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