Kaletra: Therapy With Double Protease Inhibitors
Information source: Abbott
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus
Intervention: Lopinavir/Ritonavir (Kaletra) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Stefan Simianer, MD, Study Director, Affiliation: Abbott Germany, Medical Department
Overall contact:
Beate Lohrengel, PhD, Phone: #49 6122 582087, Email: beate.lohrengel@abbott.com
Summary
Therapy with Kaletra and one other protease inhibitor in Human Immunodeficiency
Virus-patients
Clinical Details
Official title: Kaletra Double Protease Inhibitors
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Decline of virus load; reconstitution of the immune system with two protease inhibitors; evaluation of evolution of resistance mutations.
Detailed description:
This study is intended to observe and collect data on the usage, dosing, tolerability, and
efficacy of Kaletra when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free
double protease regimen and especially to show the decline of virus load and the
reconstitution of the immune system. In addition the evolution of resistance mutations
should be evaluated.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with Human Immunodeficiency Virus infection
- Patients on Kaletra and one other protease inhibitor.
Exclusion Criteria:
- Hypersensitivity against Kaletra or other ingredients.
- Severe liver insufficiency.
- No concommitant astemizole, terfenadine, oral midazolame, triazolame, cisapride,
pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine,
vardenafil and St. John's wort.
Locations and Contacts
Beate Lohrengel, PhD, Phone: #49 6122 582087, Email: beate.lohrengel@abbott.com
Site Reference ID/Investigator# 28109, Berlin D-10243, Germany; Completed
Site Reference ID/Investigator# 28131, Berlin 10551, Germany; Completed
Site Reference ID/Investigator# 48283, Berlin 10439, Germany; Recruiting
Site Reference ID/Investigator# 48283, Principal Investigator
Site Reference ID/Investigator# 28123, Berlin 13347, Germany; Completed
Site Reference ID/Investigator# 28115, Dortmund 44137, Germany; Completed
Site Reference ID/Investigator# 28124, Frankfurt 60311, Germany; Completed
Site Reference ID/Investigator# 28119, Frankfurt 60596, Germany; Completed
Site Reference ID/Investigator# 28127, Frankfurt 60329, Germany; Completed
Site Reference ID/Investigator# 5318, Krefeld 47800, Germany; Completed
Site Reference ID/Investigator# 28112, Ludwigshafen 67063, Germany; Completed
Site Reference ID/Investigator# 28129, Muenster 48149, Germany; Completed
Site Reference ID/Investigator# 28111, Muenster 48143, Germany; Completed
Site Reference ID/Investigator# 28118, Munich 80337, Germany; Completed
Site Reference ID/Investigator# 28113, Munich 80801, Germany; Completed
Site Reference ID/Investigator# 28133, Stuttgart 70197, Germany; Completed
Site Reference ID/Investigator# 28126, Wuppertal 42277, Germany; Completed
Additional Information
Starting date: January 2004
Last updated: August 9, 2011
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