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Evaluation of Kaletra Therapy Over the Long-term

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Immunodeficiency Virus

Intervention: Lopinavir/Ritonavir (Kaletra) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Stefan Simianer, MD, Study Director, Affiliation: Abbott Germany, Medical Department

Summary

Long term observation of patients under lopinavir/ritonavir containing therapy

Clinical Details

Official title: Evaluation of Kaletra Therapy Over the Long-term

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs

Secondary outcome:

Percentage of Patients With HIV-1 RNA <50 Copies/ml

Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml

Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml

Percentage of Patients With HIV-1 RNA >500 Copies/ml

Change in Absolute CD4 Cell Count [CD4+ Cells/µL]

Detailed description: Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks). These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients infected by HIV-1

- Age greater than or equal to 18 years

Exclusion Criteria:

- as described in SmPC (summary of product characteristics) at the time of prescription

Locations and Contacts

Site Ref # / Investigator 27706, Aachen 52062, Germany

Site Ref # / Investigator 52972, Aachen 52062, Germany

Site Ref # / Investigator 27639, Berlin 13347, Germany

Site Ref # / Investigator 27651, Berlin 10439, Germany

Site Ref # / Investigator 27660, Berlin 10117, Germany

Site Ref # / Investigator 27909, Berlin D-10243, Germany

Site Ref # / Investigator 27912, Berlin 10439, Germany

Site Ref # / Investigator 27929, Berlin 10589, Germany

Site Ref # / Investigator 27937, Berlin 10117, Germany

Site Ref # / Investigator 27965, Berlin 10777, Germany

Site Ref # / Investigator 47113, Berlin D-10243, Germany

Site Ref # / Investigator 52970, Berlin 13347, Germany

Site Ref # / Investigator 52971, Berlin 10707, Germany

Site Ref # / Investigator 52973, Berlin 10117, Germany

Site Ref # / Investigator 52984, Berlin 10961, Germany

Site Ref # / Investigator 53468, Berlin 10707, Germany

Site Reference ID/Investigator# 27544, Berlin 10439, Germany

Site Reference ID/Investigator# 27547, Berlin 10777, Germany

Site Reference ID/Investigator# 27552, Berlin 10777, Germany

Site Reference ID/Investigator# 27562, Berlin 10777, Germany

Site Reference ID/Investigator# 27567, Berlin 10551, Germany

Site Reference ID/Investigator# 27629, Berlin 10243, Germany

Site Reference ID/Investigator# 27574, Chemnitz 09113, Germany

Site Ref # / Investigator 27932, Cologne 50679, Germany

Site Ref # / Investigator 28060, Cologne 50674, Germany

Site Ref # / Investigator 48233, Cologne 50931, Germany

Site Ref # / Investigator 52978, Cologne 50674, Germany

Site Ref # / Investigator 52979, Cologne 50679, Germany

Site Ref # / Investigator 52985, Cologne 50931, Germany

Site Ref # / Investigator 53464, Cologne 50931, Germany

Site Ref # / Investigator 27704, Dortmund 44137, Germany

Site Ref # / Investigator 27947, Dortmund 44137, Germany

Site Ref # / Investigator 52968, Dortmund 44137, Germany

Site Ref # / Investigator 28056, Duesseldorf 40237, Germany

Site Reference ID/Investigator# 27558, Duisburg 47259, Germany

Site Ref # / Investigator 27928, Frankfurt 60311, Germany

Site Ref # / Investigator 52967, Frankfurt 60311, Germany

Site Ref # / Investigator 52983, Frankfurt 15232, Germany

Site Reference ID/Investigator# 27565, Freiburg 79106, Germany

Site Ref # / Investigator 53465, Fuerth D-90762, Germany

Site Reference ID/Investigator# 27566, Fuerth 90762, Germany

Site Ref # / Investigator 27931, Hamburg 20099, Germany

Site Ref # / Investigator 27982, Hamburg 20099, Germany

Site Ref # / Investigator 28032, Hamburg 20246, Germany

Site Ref # / Investigator 30864, Hamburg 20146, Germany

Site Ref # / Investigator 47114, Hamburg 20099, Germany

Site Ref # / Investigator 47115, Hamburg 20099, Germany

Site Ref # / Investigator 52969, Hamburg 20246, Germany

Site Ref # / Investigator 52980, Hamburg 20354, Germany

Site Ref # / Investigator 53467, Hamburg 20246, Germany

Site Ref # / Investigator 5348, Hamburg 20146, Germany

Site Reference ID/Investigator# 27546, Hamburg 20146, Germany

Site Reference ID/Investigator# 27551, Hamburg 20099, Germany

Site Reference ID/Investigator# 27634, Hamburg 20099, Germany

Site Ref # / Investigator 27641, Karlsruhe 76135, Germany

Site Ref # / Investigator 27964, Karlsruhe 76135, Germany

Site Reference ID/Investigator# 27561, Karlsruhe 76135, Germany

Site Ref # / Investigator 53466, Koblenz 56065, Germany

Site Reference ID/Investigator# 27555, Koblenz 56065, Germany

Site Ref # / Investigator 27905, Krefeld 47800, Germany

Site Ref # / Investigator 27906, Leipzig 04107, Germany

Site Ref # / Investigator 52975, Leipzig 04107, Germany

Site Ref # / Investigator 53463, Leipzig 04107, Germany

Site Ref # / Investigator 27948, Ludwigshafen 67063, Germany

Site Ref # / Investigator 52977, Ludwigshafen 67063, Germany

Site Ref # / Investigator 27902, Mainz 55116, Germany

Site Reference ID/Investigator# 27543, Mainz 55116, Germany

Site Ref # / Investigator 28104, Moenchengladbach 41061, Germany

Site Ref # / Investigator 52981, Moenchengladbach 41061, Germany

Site Ref # / Investigator 27648, Muenster 48149, Germany

Site Reference ID/Investigator# 27568, Muenster 48149, Germany

Site Ref # / Investigator 27926, Munich 80801, Germany

Site Ref # / Investigator 27949, Munich 80337, Germany

Site Ref # / Investigator 53462, Munich 80801, Germany

Site Reference ID/Investigator# 27553, Munich 80337, Germany

Site Ref # / Investigator 52982, Nuernberg 90419, Germany

Site Ref # / Investigator 27988, Oldenburg 26121, Germany

Site Reference ID/Investigator# 27563, Oldenburg 26121, Germany

Site Ref # / Investigator 27637, Osnabrueck 49076, Germany

Site Ref # / Investigator 27943, Osnabrueck 49076, Germany

Site Ref # / Investigator 52974, Osnabrueck 49076, Germany

Site Ref # / Investigator 27939, Paderborn 33100, Germany

Site Ref # / Investigator 27649, Rostock 18057, Germany

Site Reference ID/Investigator# 27569, Rostock D-18057, Germany

Site Ref # / Investigator 27647, Stuttgart 70197, Germany

Site Ref # / Investigator 28047, Stuttgart 70197, Germany

Site Ref # / Investigator 28048, Stuttgart 70197, Germany

Site Reference ID/Investigator# 27631, Stuttgart 70197, Germany

Site Ref # / Investigator 52976, Troisdorf 53840, Germany

Site Ref # / Investigator 27961, Wuppertal 42277, Germany

Additional Information

Starting date: June 2001
Last updated: August 9, 2011

Page last updated: August 23, 2015

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