Clinical trial NCT01083810: Evaluation of Kaletra Therapy Over the Long-term
Official title: Evaluation of Kaletra Therapy Over the Long-term
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
Infection
Kaletra
Resistance
Mutations
alternative Therapy regimen
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human Immunodeficiency Virus-infected, protease inhibitor-naïve patients from a clinical setting

Brief summary: Long term observation of patients under lopinavir/ritonavir containing therapy

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 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

Primary outcomes:
measure: Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
timeFrame: Baseline and at any timepoint where testing is possible
Secondary outcomes:
measure: Percentage of Patients With HIV-1 RNA <50 Copies/ml
timeFrame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
measure: Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
timeFrame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
measure: Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
timeFrame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
measure: Percentage of Patients With HIV-1 RNA >500 Copies/ml
timeFrame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
measure: Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
timeFrame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Site Ref # / Investigator 27706
city: Aachen
country: Germany
facility: Site Ref # / Investigator 52972
city: Berlin
country: Germany
facility: Site Ref # / Investigator 27660
city: Berlin
country: Germany
facility: Site Ref # / Investigator 27937
city: Berlin
country: Germany
facility: Site Ref # / Investigator 52973
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 27629
city: Berlin
country: Germany
facility: Site Ref # / Investigator 27651
city: Berlin
country: Germany
facility: Site Ref # / Investigator 27912
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 27544
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 27567
city: Berlin
country: Germany
facility: Site Ref # / Investigator 27929
city: Berlin
country: Germany
facility: Site Ref # / Investigator 52971
city: Berlin
country: Germany
facility: Site Ref # / Investigator 53468
city: Berlin
country: Germany
facility: Site Ref # / Investigator 27965
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 27547
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 27552
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 27562
city: Berlin
country: Germany
facility: Site Ref # / Investigator 52984
city: Berlin
country: Germany
facility: Site Ref # / Investigator 27639
city: Berlin
country: Germany
facility: Site Ref # / Investigator 52970
city: Berlin
country: Germany
facility: Site Ref # / Investigator 27909
city: Berlin
country: Germany
facility: Site Ref # / Investigator 47113
city: Chemnitz
country: Germany
facility: Site Reference ID/Investigator# 27574
city: Cologne
country: Germany
facility: Site Ref # / Investigator 28060
city: Cologne
country: Germany
facility: Site Ref # / Investigator 52978
city: Cologne
country: Germany
facility: Site Ref # / Investigator 27932
city: Cologne
country: Germany
facility: Site Ref # / Investigator 52979
city: Cologne
country: Germany
facility: Site Ref # / Investigator 48233
city: Cologne
country: Germany
facility: Site Ref # / Investigator 52985
city: Cologne
country: Germany
facility: Site Ref # / Investigator 53464
city: Dortmund
country: Germany
facility: Site Ref # / Investigator 27704
city: Dortmund
country: Germany
facility: Site Ref # / Investigator 27947
city: Dortmund
country: Germany
facility: Site Ref # / Investigator 52968
city: Duesseldorf
country: Germany
facility: Site Ref # / Investigator 28056
city: Duisburg
country: Germany
facility: Site Reference ID/Investigator# 27558
city: Frankfurt
country: Germany
facility: Site Ref # / Investigator 52983
city: Frankfurt
country: Germany
facility: Site Ref # / Investigator 27928
city: Frankfurt
country: Germany
facility: Site Ref # / Investigator 52967
city: Freiburg
country: Germany
facility: Site Reference ID/Investigator# 27565
city: Fuerth
country: Germany
facility: Site Reference ID/Investigator# 27566
city: Fuerth
country: Germany
facility: Site Ref # / Investigator 53465
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 27931
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 27982
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 47114
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 47115
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 27551
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 27634
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 30864
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 5348
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 27546
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 28032
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 52969
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 53467
city: Hamburg
country: Germany
facility: Site Ref # / Investigator 52980
city: Karlsruhe
country: Germany
facility: Site Ref # / Investigator 27641
city: Karlsruhe
country: Germany
facility: Site Ref # / Investigator 27964
city: Karlsruhe
country: Germany
facility: Site Reference ID/Investigator# 27561
city: Koblenz
country: Germany
facility: Site Ref # / Investigator 53466
city: Koblenz
country: Germany
facility: Site Reference ID/Investigator# 27555
city: Krefeld
country: Germany
facility: Site Ref # / Investigator 27905
city: Leipzig
country: Germany
facility: Site Ref # / Investigator 27906
city: Leipzig
country: Germany
facility: Site Ref # / Investigator 52975
city: Leipzig
country: Germany
facility: Site Ref # / Investigator 53463
city: Ludwigshafen
country: Germany
facility: Site Ref # / Investigator 27948
city: Ludwigshafen
country: Germany
facility: Site Ref # / Investigator 52977
city: Mainz
country: Germany
facility: Site Ref # / Investigator 27902
city: Mainz
country: Germany
facility: Site Reference ID/Investigator# 27543
city: Moenchengladbach
country: Germany
facility: Site Ref # / Investigator 28104
city: Moenchengladbach
country: Germany
facility: Site Ref # / Investigator 52981
city: Muenster
country: Germany
facility: Site Ref # / Investigator 27648
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 27568
city: Munich
country: Germany
facility: Site Ref # / Investigator 27949
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 27553
city: Munich
country: Germany
facility: Site Ref # / Investigator 27926
city: Munich
country: Germany
facility: Site Ref # / Investigator 53462
city: Nuernberg
country: Germany
facility: Site Ref # / Investigator 52982
city: Oldenburg
country: Germany
facility: Site Ref # / Investigator 27988
city: Oldenburg
country: Germany
facility: Site Reference ID/Investigator# 27563
city: Osnabrueck
country: Germany
facility: Site Ref # / Investigator 27637
city: Osnabrueck
country: Germany
facility: Site Ref # / Investigator 27943
city: Osnabrueck
country: Germany
facility: Site Ref # / Investigator 52974
city: Paderborn
country: Germany
facility: Site Ref # / Investigator 27939
city: Rostock
country: Germany
facility: Site Ref # / Investigator 27649
city: Rostock
country: Germany
facility: Site Reference ID/Investigator# 27569
city: Stuttgart
country: Germany
facility: Site Ref # / Investigator 27647
city: Stuttgart
country: Germany
facility: Site Ref # / Investigator 28047
city: Stuttgart
country: Germany
facility: Site Ref # / Investigator 28048
city: Stuttgart
country: Germany
facility: Site Reference ID/Investigator# 27631
city: Troisdorf
country: Germany
facility: Site Ref # / Investigator 52976
city: Wuppertal
country: Germany
facility: Site Ref # / Investigator 27961
Study officials:
affiliation: Abbott Germany, Medical Department
name: Stefan Simianer, MD
role: STUDY_DIRECTOR
References: