Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use

NCT ID: NCT01379703

Last Updated: 2011-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2288 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2010-02-28

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.

Conditions

HIV-1 Patients

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Single patients group

Single HIV-1 infected patients group

No interventions assigned to this group

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maja Hojnik, MD, PhD

Role: STUDY_DIRECTOR

Abbott International

Locations

Site Ref # / Investigator 57102

Brno, , Czechia

Site Ref # / Investigator 57054

České Budějovice, , Czechia

Site Ref # / Investigator 57055

Hradec Králové, , Czechia

Site Ref # / Investigator 57056

Ostrava, , Czechia

Site Ref # / Investigator 57052

Pilsen, , Czechia

Site Ref # / Investigator 5344

Prague, , Czechia

Site Ref # / Investigator 57053

Ústí nad Labem, , Czechia

Site Ref # / Investigator 7576

Tbilisi, , Georgia

Site Ref # / Investigator 57050

Beersheba, , Israel

Site Ref # / Investigator 57048

Haifa, , Israel

Site Ref # / Investigator 57049

Jerusalem, , Israel

Site Ref # / Investigator 6124

Kfar Saba, , Israel

Site Ref # / Investigator 57047

Rehovot, , Israel

Site Ref # / Investigator 57051

Tel Litwinsky, , Israel

Site Ref # / Investigator 7578

Riga, , Latvia

Site Ref # / Investigator 6127

Vilnius, , Lithuania

Site Ref # / Investigator 6190

Bialystok, , Poland

Site Ref # / Investigator 56885

Bydgoszcz, , Poland

Site Ref # / Investigator 56887

Chorzów, , Poland

Site Ref # / Investigator 56883

Gdansk, , Poland

Site Ref # / Investigator 56888

Krakow, , Poland

Site Ref # / Investigator 56889

Lodz, , Poland

Site Ref # / Investigator 56884

Poznan, , Poland

Site Ref # / Investigator 56886

Szczecin, , Poland

Site Ref # / Investigator 56882

Warsaw, , Poland

Site Ref # / Investigator 56890

Wroclaw, , Poland

Site Ref # / Investigator 57064

Brasov, , Romania

Site Ref # / Investigator 6194

Bucharest, , Romania

Site Ref # / Investigator 57062

Bucharest, , Romania

Site Ref # / Investigator 57063

Constanța, , Romania

Site Ref # / Investigator 57067

Craiova, , Romania

Site Ref # / Investigator 57068

Iași, , Romania

Site Ref # / Investigator 57065

Târgu Mureş, , Romania

Site Ref # / Investigator 57066

Timișoara, , Romania

Site Ref # / Investigator 57022

Barnaul, , Russia

Site Ref # / Investigator 56918

Chelyabinsk, , Russia

Site Ref # / Investigator 56963

Chita, , Russia

Site Ref # / Investigator 56921

Irkutsk, , Russia

Site Ref #/Investigator 57104

Irkutsk, , Russia

Site Ref # / Investigator 57028

Ivanovo, , Russia

Site Ref # / Investigator 57036

Izhevsk, , Russia

Site Ref # / Investigator 56945

Kaliningrad, , Russia

Site Ref # / Investigator 56909

Kazan', , Russia

Site Ref # / Investigator 57037

Kemerovo, , Russia

Site Ref #/Investigator 57105

Kemerovo, , Russia

Site Ref # / Investigator 56948

Khabarovsk, , Russia

Site Ref # / Investigator 56932

Khanty-Mansiysk, , Russia

Site Ref #/Investigator 57107

Kirov, , Russia

Site Ref # / Investigator 57030

Kostroma, , Russia

Site Ref # / Investigator 56943

Krasnodar, , Russia

Site Ref # / Investigator 56928

Krasnoyarsk, , Russia

Site Ref #/Investigator 57106

Krasnoyarsk, , Russia

Site Ref # / Investigator 57021

Kurgan, , Russia

Site Ref # / Investigator 57025

Lipetsk, , Russia

Site Ref # / Investigator 56944

Magnitogorsk, , Russia

Site Ref # / Investigator 56904

Moscow, , Russia

Site Ref # / Investigator 6209

Moscow, , Russia

Site Ref # / Investigator 56902

Moscow, , Russia

Site Ref # / Investigator 57024

Murmansk, , Russia

Site Ref # / Investigator 56907

Nizhny Novgorod, , Russia

Site Ref # / Investigator 56964

Noril'sk, , Russia

Site Ref # / Investigator 56929

Novokuznetsk, , Russia

Site Ref # / Investigator 56942

Novosibirsk, , Russia

Site Ref # / Investigator 56926

Noyabrsk, , Russia

Site Ref # / Investigator 56915

Orenburg, , Russia

Site Ref # / Investigator 57031

Orenburg, , Russia

Site Ref # / Investigator 56930

Perm, , Russia

Site Ref # / Investigator 56911

Rostov-on-Don, , Russia

Site Ref # / Investigator 57033

Saint Petersburg, , Russia

Site Ref # / Investigator 56906

Saint Petersburg, , Russia

Site Ref # / Investigator 56905

Saint Petersburg, , Russia

Site Ref # / Investigator 56920

Saint Petersburg, , Russia

Site Ref # / Investigator 57038

Saint Petersburg, , Russia

Site Ref # / Investigator 56931

Samara, , Russia

Site Ref # / Investigator 56913

Saratov, , Russia

Site Ref # / Investigator 56908

Surgut, , Russia

Site Ref # / Investigator 56962

Tolyatti, , Russia

Site Ref # / Investigator 57034

Tula, , Russia

Site Ref # / Investigator 56947

Tver', , Russia

Site Ref # / Investigator 57035

Tver', , Russia

Site Ref # / Investigator 56910

Tyumen, , Russia

Site Ref # / Investigator 56919

Tyumen, , Russia

Site Ref # / Investigator 57029

Ufa, , Russia

Site Ref # / Investigator 56949

Ulan-Ude, , Russia

Site Ref # / Investigator 56914

Ulyanovsk, , Russia

Site Ref # / Investigator 57027

Vladimir, , Russia

Site Ref # / Investigator 56916

Volgograd, , Russia

Site Ref #/Investigator 57103

Vologda, , Russia

Site Ref # / Investigator 56946

Yakutsk, , Russia

Site Ref # / Investigator 57026

Yaroslavl, , Russia

Site Ref # / Investigator 56923

Yekaterinburg, , Russia

Site Ref # / Investigator 56903

Yekaterinburg, , Russia

Site Ref # / Investigator 7579

Belgrade, , Serbia

Site Ref # / Investigator 6208

Bratislava, , Slovakia

Site Ref # / Investigator 6199

Ljubljana, , Slovenia

Site Ref # / Investigator 57042

Dnipro, , Ukraine

Site Ref # / Investigator 57043

Donetsk, , Ukraine

Site Ref # / Investigator 57045

Kyiv, , Ukraine

Site Ref # / Investigator 6191

Kyiv, , Ukraine

Site Ref # / Investigator 57046

Kyiv, , Ukraine

Site Ref # / Investigator 57044

Mykolaiv, , Ukraine

Site Ref # / Investigator 57039

Odesa, , Ukraine

Site Ref # / Investigator 57040

Simferopol, , Ukraine

Countries

Czechia; Georgia; Israel; Latvia; Lithuania; Poland; Romania; Russia; Serbia; Slovakia; Slovenia; Ukraine

Other Identifiers

PMOS-EAST-04-1

Identifier Type: -

Identifier Source: org_study_id