Clinical trial NCT01379703: Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
Official title: Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Patients
Keywords: HIV-1 infected patients
Protease inhibitor
Kaletra®
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 2288
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: KaleEAST is non-interventional, observational study in which Kaletra® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regard to dose, population and indication.

Brief summary: KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients.

The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries.

The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.

Detailed description: As this study is observational in nature, subject follow-up was not specified by the protocol but was left to the judgment of each physician within the 18 months period, which defines the survey for each participant. For indicative purposes, follow-up of each participant should enable approximately 7 visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following inclusion (usually at the end of the first treatment month) and apart from visits required because of intercurrent events. Participant visits were assigned as follows: Baseline/Day 0 (start of lopinavir/ritonavir treatment), Month 1 (day 1 to day 45), Month 3 (day 46 to day 136), Month 6 (day 137 to day 228), Month 9 (day 229 to day 319), Month 12 (day 320 to day 410), Month 15 (day 411 to day 501), Month 18 (day 502 to day 593). Each participant is planned to be observed during his/her lopinavir/ritonavir capsule containing treatment regimen for a maximum period of 18 months, and each participant is planned to be observed during his/her lopinavir/ritonavir tablet containing treatment regimen for a maximum period of 9 months.

Eligibility criteria: Inclusion Criteria:

Patients infected by HIV-1 infection who are either:

* Antiretroviral treatment (ART) naive or
* Had failed or had been intolerant to one previous combined antiretroviral treatment (cART), not including a Protease inhibitor (PI) (first-line pretreated without a Protease inhibitor) or
* Had failed or had been intolerant to one previous antiretroviral treatment ART, including one Protease inhibitor (first-line pretreated with a Protease Inhibitor).

A ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.

Exclusion Criteria:

* Treatment with drugs at risk for interactions with lopinavir/ritonavir
* Uncontrolled AIDS defining disease
* Two or more previous Protease inhibitors (PIs)
* Participation in another study or clinical trial

Primary outcomes:
measure: CD4 Count
timeFrame: Baseline
measure: Changes in CD4 Count
timeFrame: Baseline to 1 month
measure: Changes in CD4 Count
timeFrame: Baseline to 3 months
measure: Changes in CD4 Count
timeFrame: Baseline to 6 months
measure: Changes in CD4 Count
timeFrame: Baseline to 9 months
measure: Changes in CD4 Count
timeFrame: Baseline to 12 months
measure: Changes in CD4 Count
timeFrame: Baseline to 15 months
measure: Changes in CD4 Count
timeFrame: Baseline to 18 months
measure: Viral Load
timeFrame: Baseline
measure: Viral Load
timeFrame: 1 month
measure: Viral Load
timeFrame: 3 months
measure: Viral Load
timeFrame: 6 months
measure: Viral Load
timeFrame: 9 months
measure: Viral Load
timeFrame: 12 months
measure: Viral Load
timeFrame: 15 months
measure: Viral Load
timeFrame: 18 months
measure: Laboratory Parameter Blood Glucose
timeFrame: Baseline, 9 months, 18 months
measure: Laboratory Parameter Transaminases
timeFrame: Baseline, 9 months, 18 months
measure: Laboratory Parameter Lipids
timeFrame: Baseline, 9 months, 18 months
Secondary outcomes:
measure: Reasons for Discontinuation of Lopinavir/Ritonavir
timeFrame: 9 months
measure: Reasons for Discontinuation of Lopinavir/Ritonavir
timeFrame: 18 months
measure: Compliance With Lopinavir/Ritonavir
timeFrame: 9 months
measure: Compliance With Lopinavir/Ritonavir
timeFrame: 18 months
measure: Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
timeFrame: 18 months
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Site Ref # / Investigator 57102
city: Ceske Budejovice
country: Czech Republic
facility: Site Ref # / Investigator 57054
city: Hradec Kralove
country: Czech Republic
facility: Site Ref # / Investigator 57055
city: Ostrava
country: Czech Republic
facility: Site Ref # / Investigator 57056
city: Plzen
country: Czech Republic
facility: Site Ref # / Investigator 57052
city: Prague 8
country: Czech Republic
facility: Site Ref # / Investigator 5344
city: Usti nad Labem
country: Czech Republic
facility: Site Ref # / Investigator 57053
city: Tbilisi
country: Georgia
facility: Site Ref # / Investigator 7576
city: Beer-Sheva
country: Israel
facility: Site Ref # / Investigator 57050
city: Haifa
country: Israel
facility: Site Ref # / Investigator 57048
city: Jerusalem
country: Israel
facility: Site Ref # / Investigator 57049
city: Kfar Saba
country: Israel
facility: Site Ref # / Investigator 6124
city: Rechovot
country: Israel
facility: Site Ref # / Investigator 57047
city: Tel-Hashomer
country: Israel
facility: Site Ref # / Investigator 57051
city: Riga
country: Latvia
facility: Site Ref # / Investigator 7578
city: Vilnius
country: Lithuania
facility: Site Ref # / Investigator 6127
city: Bialystok
country: Poland
facility: Site Ref # / Investigator 6190
city: Bydgoszcz
country: Poland
facility: Site Ref # / Investigator 56885
city: Chorzow
country: Poland
facility: Site Ref # / Investigator 56887
city: Gdansk
country: Poland
facility: Site Ref # / Investigator 56883
city: Krakow
country: Poland
facility: Site Ref # / Investigator 56888
city: Lodz
country: Poland
facility: Site Ref # / Investigator 56889
city: Poznan
country: Poland
facility: Site Ref # / Investigator 56884
city: Szczecin
country: Poland
facility: Site Ref # / Investigator 56886
city: Warsaw
country: Poland
facility: Site Ref # / Investigator 56882
city: Wroclaw
country: Poland
facility: Site Ref # / Investigator 56890
city: Brasov
country: Romania
facility: Site Ref # / Investigator 57064
city: Bucharest
country: Romania
facility: Site Ref # / Investigator 6194
city: Bucharest
country: Romania
facility: Site Ref # / Investigator 57062
city: Constanta
country: Romania
facility: Site Ref # / Investigator 57063
city: Craiova
country: Romania
facility: Site Ref # / Investigator 57067
city: Iasi
country: Romania
facility: Site Ref # / Investigator 57068
city: Targu Mures
country: Romania
facility: Site Ref # / Investigator 57065
city: Timisoara
country: Romania
facility: Site Ref # / Investigator 57066
city: Barnaul
country: Russian Federation
facility: Site Ref # / Investigator 57022
city: Chelyabinsk
country: Russian Federation
facility: Site Ref # / Investigator 56918
city: Chita
country: Russian Federation
facility: Site Ref # / Investigator 56963
city: Ekaterinburg
country: Russian Federation
facility: Site Ref # / Investigator 56923
city: Ekaterinburg
country: Russian Federation
facility: Site Ref # / Investigator 56903
city: Irkutsk
country: Russian Federation
facility: Site Ref # / Investigator 56921
city: Irkutsk
country: Russian Federation
facility: Site Ref #/Investigator 57104
city: Ivanovo
country: Russian Federation
facility: Site Ref # / Investigator 57028
city: Izhevsk
country: Russian Federation
facility: Site Ref # / Investigator 57036
city: Kaliningrad
country: Russian Federation
facility: Site Ref # / Investigator 56945
city: Kazan
country: Russian Federation
facility: Site Ref # / Investigator 56909
city: Kemerovo
country: Russian Federation
facility: Site Ref # / Investigator 57037
city: Kemerovo
country: Russian Federation
facility: Site Ref #/Investigator 57105
city: Khabarovsk
country: Russian Federation
facility: Site Ref # / Investigator 56948
city: Khanty-Mansiysk
country: Russian Federation
facility: Site Ref # / Investigator 56932
city: Kirov
country: Russian Federation
facility: Site Ref #/Investigator 57107
city: Kostroma
country: Russian Federation
facility: Site Ref # / Investigator 57030
city: Krasnodar
country: Russian Federation
facility: Site Ref # / Investigator 56943
city: Krasnoyarsk
country: Russian Federation
facility: Site Ref # / Investigator 56928
city: Krasnoyarsk
country: Russian Federation
facility: Site Ref #/Investigator 57106
city: Kurgan
country: Russian Federation
facility: Site Ref # / Investigator 57021
city: Lipetsk
country: Russian Federation
facility: Site Ref # / Investigator 57025
city: Magnitogorsk
country: Russian Federation
facility: Site Ref # / Investigator 56944
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 56904
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 6209
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 56902
city: Murmansk
country: Russian Federation
facility: Site Ref # / Investigator 57024
city: Nizhniy Novgorod
country: Russian Federation
facility: Site Ref # / Investigator 56907
city: Norilsk
country: Russian Federation
facility: Site Ref # / Investigator 56964
city: Novokuznetsk
country: Russian Federation
facility: Site Ref # / Investigator 56929
city: Novosibirsk
country: Russian Federation
facility: Site Ref # / Investigator 56942
city: Noyabrsk
country: Russian Federation
facility: Site Ref # / Investigator 56926
city: Orenburg
country: Russian Federation
facility: Site Ref # / Investigator 56915
city: Orenburg
country: Russian Federation
facility: Site Ref # / Investigator 57031
city: Perm
country: Russian Federation
facility: Site Ref # / Investigator 56930
city: Rostov-on-Don
country: Russian Federation
facility: Site Ref # / Investigator 56911
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 56906
city: Saint Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 56905
city: Samara
country: Russian Federation
facility: Site Ref # / Investigator 56931
city: Saratov
country: Russian Federation
facility: Site Ref # / Investigator 56913
city: St. Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 57033
city: St. Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 56920
city: St. Petersburg
country: Russian Federation
facility: Site Ref # / Investigator 57038
city: Surgut
country: Russian Federation
facility: Site Ref # / Investigator 56908
city: Togliatti
country: Russian Federation
facility: Site Ref # / Investigator 56962
city: Tula
country: Russian Federation
facility: Site Ref # / Investigator 57034
city: Tver
country: Russian Federation
facility: Site Ref # / Investigator 56947
city: Tver
country: Russian Federation
facility: Site Ref # / Investigator 57035
city: Tyumen
country: Russian Federation
facility: Site Ref # / Investigator 56910
city: Tyumen
country: Russian Federation
facility: Site Ref # / Investigator 56919
city: Ufa
country: Russian Federation
facility: Site Ref # / Investigator 57029
city: Ulan-Ude
country: Russian Federation
facility: Site Ref # / Investigator 56949
city: Ulyanovsk
country: Russian Federation
facility: Site Ref # / Investigator 56914
city: Vladimir
country: Russian Federation
facility: Site Ref # / Investigator 57027
city: Volgograd
country: Russian Federation
facility: Site Ref # / Investigator 56916
city: Vologda
country: Russian Federation
facility: Site Ref #/Investigator 57103
city: Yakutsk
country: Russian Federation
facility: Site Ref # / Investigator 56946
city: Yaroslavl
country: Russian Federation
facility: Site Ref # / Investigator 57026
city: Belgrade
country: Serbia
facility: Site Ref # / Investigator 7579
city: Bratislava
country: Slovakia
facility: Site Ref # / Investigator 6208
city: Ljubljana
country: Slovenia
facility: Site Ref # / Investigator 6199
city: Dnepropetrovsk
country: Ukraine
facility: Site Ref # / Investigator 57042
city: Donetsk
country: Ukraine
facility: Site Ref # / Investigator 57043
city: Kyiv
country: Ukraine
facility: Site Ref # / Investigator 57045
city: Kyiv
country: Ukraine
facility: Site Ref # / Investigator 6191
city: Kyiv
country: Ukraine
facility: Site Ref # / Investigator 57046
city: Mykolaiv
country: Ukraine
facility: Site Ref # / Investigator 57044
city: Odessa
country: Ukraine
facility: Site Ref # / Investigator 57039
city: Simferopol
country: Ukraine
facility: Site Ref # / Investigator 57040
Study officials:
affiliation: Abbott International
name: Maja Hojnik, MD, PhD
role: STUDY_DIRECTOR
References: