HIV-1 PatientsKaleEASTNCT01379703
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
An observational study of HIV-1 Patients, run by Abbott at 103 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- HIV-1 Patients
- How many people
- 2,288 participants
- Where
- 103 sitesin 12 countries
- Study dates
- Feb 2004to Feb 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
103 sites in 12 countries.
103 sites in 12 countries
Russia58 sites
Site Ref # / Investigator 57022
Barnaul, 658610
Site Ref # / Investigator 56918
Chelyabinsk, 454052
Site Ref # / Investigator 56963
Chita, 672000
Site Ref # / Investigator 56921
Irkutsk, 664043
Site Ref #/Investigator 57104
Irkutsk, 664043
Site Ref # / Investigator 57028
Ivanovo, 153000
Site Ref # / Investigator 57036
Izhevsk, 426067
Site Ref # / Investigator 56945
Kaliningrad, 2360000
Site Ref # / Investigator 56909
Kazan', 420000
Site Ref # / Investigator 57037
Kemerovo, 650056
Site Ref #/Investigator 57105
Kemerovo, 650056
Site Ref # / Investigator 56948
Khabarovsk, 680029
Site Ref # / Investigator 56932
Khanty-Mansiysk, 628002
Site Ref #/Investigator 57107
Kirov, 57107
Site Ref # / Investigator 57030
Kostroma, 156007
Site Ref # / Investigator 56943
Krasnodar, 350015
Site Ref # / Investigator 56928
Krasnoyarsk, 660049
Site Ref #/Investigator 57106
Krasnoyarsk, 660049
Site Ref # / Investigator 57021
Kurgan, 640007
Site Ref # / Investigator 57025
Lipetsk, 398043
Site Ref # / Investigator 56944
Magnitogorsk, 350015
Site Ref # / Investigator 56904
Moscow, 105275
Site Ref # / Investigator 6209
Moscow, 105275
Site Ref # / Investigator 56902
Moscow, 129110
Site Ref # / Investigator 57024
Murmansk, 183047
Site Ref # / Investigator 56907
Nizhny Novgorod, 603005
Site Ref # / Investigator 56964
Noril'sk, 663318
Site Ref # / Investigator 56929
Novokuznetsk, 654031
Site Ref # / Investigator 56942
Novosibirsk, 630000
Site Ref # / Investigator 56926
Noyabrsk, 629806
Site Ref # / Investigator 56915
Orenburg, 460035
Site Ref # / Investigator 57031
Orenburg, 460035
Site Ref # / Investigator 56930
Perm, 614000
Site Ref # / Investigator 56911
Rostov-on-Don, 344006
Site Ref # / Investigator 57033
Saint Petersburg, 190000
Site Ref # / Investigator 56906
Saint Petersburg, 190103
Site Ref # / Investigator 56905
Saint Petersburg, 191167
Site Ref # / Investigator 56920
Saint Petersburg, 196645
Site Ref # / Investigator 57038
Saint Petersburg, 196645
Site Ref # / Investigator 56931
Samara, 443041
Site Ref # / Investigator 56913
Saratov, 410009
Site Ref # / Investigator 56908
Surgut, 628400
Site Ref # / Investigator 56962
Tolyatti, 445846
Site Ref # / Investigator 57034
Tula, 300002
Site Ref # / Investigator 56947
Tver', 170024
Site Ref # / Investigator 57035
Tver', 170024
Site Ref # / Investigator 56910
Tyumen, 628602
Site Ref # / Investigator 56919
Tyumen, 628602
Site Ref # / Investigator 57029
Ufa, 450077
Site Ref # / Investigator 56949
Ulan-Ude, 670034
Site Ref # / Investigator 56914
Ulyanovsk, 432071
Site Ref # / Investigator 57027
Vladimir, 600023
Site Ref # / Investigator 56916
Volgograd, 400040
Site Ref #/Investigator 57103
Vologda, 160002
Site Ref # / Investigator 56946
Yakutsk, 677004
Site Ref # / Investigator 57026
Yaroslavl, 150000
Site Ref # / Investigator 56923
Yekaterinburg, 620102
Site Ref # / Investigator 56903
Yekaterinburg, 620115
Poland10 sites
Site Ref # / Investigator 6190
Bialystok, 15540
Site Ref # / Investigator 56885
Bydgoszcz, 85-030
Site Ref # / Investigator 56887
Chorzów, 41-500
Site Ref # / Investigator 56883
Gdansk, 80-214
Site Ref # / Investigator 56888
Krakow, 31-531
Site Ref # / Investigator 56889
Lodz, 91-347
Site Ref # / Investigator 56884
Poznan, 61-285
Site Ref # / Investigator 56886
Szczecin, 71-455
Site Ref # / Investigator 56882
Warsaw, 01-201
Site Ref # / Investigator 56890
Wroclaw, 51-149
Romania8 sites
Site Ref # / Investigator 57064
Brasov, 500174
Site Ref # / Investigator 6194
Bucharest, 021105
Site Ref # / Investigator 57062
Bucharest, 030303
Site Ref # / Investigator 57063
Constanța, 900708
Site Ref # / Investigator 57067
Craiova, 200515
Site Ref # / Investigator 57068
Iași, 700116
Site Ref # / Investigator 57065
Târgu Mureş, 540394
Site Ref # / Investigator 57066
Timișoara, 300310
Ukraine8 sites
Site Ref # / Investigator 57042
Dnipro, 49115
Site Ref # / Investigator 57043
Donetsk, 83045
Site Ref # / Investigator 57045
Kyiv, 01015
Site Ref # / Investigator 6191
Kyiv, 01015
Site Ref # / Investigator 57046
Kyiv, 03115
Site Ref # / Investigator 57044
Mykolaiv, 54003
Site Ref # / Investigator 57039
Odesa, 565031
Site Ref # / Investigator 57040
Simferopol, 95006
Czechia7 sites
Site Ref # / Investigator 57102
Brno, 639 00
Site Ref # / Investigator 57054
České Budějovice, 370 87
Site Ref # / Investigator 57055
Hradec Králové, 50005
Site Ref # / Investigator 57056
Ostrava, 708 52
Site Ref # / Investigator 57052
Pilsen, 305 99
Site Ref # / Investigator 5344
Prague, 180 01
Site Ref # / Investigator 57053
Ústí nad Labem, 40011
Israel6 sites
Site Ref # / Investigator 57050
Beersheba, 84101
Site Ref # / Investigator 57048
Haifa, 31096
Site Ref # / Investigator 57049
Jerusalem, 91120
Site Ref # / Investigator 6124
Kfar Saba, 44281
Site Ref # / Investigator 57047
Rehovot, 76100
Site Ref # / Investigator 57051
Tel HaShomer
About this study
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.
Read the 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
- Keywords
- HIV-1 infected patients, Protease inhibitor, Kaletra®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single patients group | Single HIV-1 infected patients group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 Count
CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.
Measured: Baseline
Changes in CD4 Count
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Measured: Baseline to 1 month
Changes in CD4 Count
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Measured: Baseline to 3 months
Changes in CD4 Count
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Measured: Baseline to 6 months
Changes in CD4 Count
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Measured: Baseline to 9 months
Changes in CD4 Count
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Measured: Baseline to 12 months
Changes in CD4 Count
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Measured: Baseline to 15 months
Changes in CD4 Count
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Measured: Baseline to 18 months
Viral Load
Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.
Measured: Baseline
Viral Load
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Measured: 1 month
Viral Load
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Measured: 3 months
Viral Load
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Measured: 6 months
Viral Load
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Measured: 9 months
Viral Load
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Measured: 12 months
Viral Load
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Measured: 15 months
Viral Load
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Measured: 18 months
Laboratory Parameter Blood Glucose
Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Measured: Baseline, 9 months, 18 months
Laboratory Parameter Transaminases
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Measured: Baseline, 9 months, 18 months
Laboratory Parameter Lipids
A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Measured: Baseline, 9 months, 18 months
Secondary outcomes (5)
Reasons for Discontinuation of Lopinavir/Ritonavir
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Measured: 9 months
Reasons for Discontinuation of Lopinavir/Ritonavir
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Measured: 18 months
Compliance With Lopinavir/Ritonavir
Participants reported whether they had missed doses of their antiretroviral treatment.
Measured: 9 months
Compliance With Lopinavir/Ritonavir
Participants reported whether they had missed any doses of their antiretroviral treatment.
Measured: 18 months
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.
All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the "Reported Adverse Events" section of this record.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startFeb 2004
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1 PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maja Hojnik, MD, PhD, Study director, Abbott International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379703
- Sponsor's protocol ID
- PMOS-EAST-04-1
- Acronym
- KaleEAST
- Status last verified
- Oct 2011
- First submitted
- 22 Jun 2011
- Last updated
- 17 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
- ClinicalTrials.gov ID
- NCT01379703
- Acronym / sponsor ID
- KaleEAST / PMOS-EAST-04-1
- Conditions
- HIV-1 Patients
- Keywords
- HIV-1 infected patients, Protease inhibitor, Kaletra®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,288 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Posted 12 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single patients group | – | –Single HIV-1 infected patients group |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CD4 Count
Time frame: Baseline
CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.
Changes in CD4 Count
Time frame: Baseline to 1 month
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Changes in CD4 Count
Time frame: Baseline to 3 months
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Changes in CD4 Count
Time frame: Baseline to 6 months
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Changes in CD4 Count
Time frame: Baseline to 9 months
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Changes in CD4 Count
Time frame: Baseline to 12 months
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Changes in CD4 Count
Time frame: Baseline to 15 months
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Changes in CD4 Count
Time frame: Baseline to 18 months
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Viral Load
Time frame: Baseline
Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.
Viral Load
Time frame: 1 month
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Viral Load
Time frame: 3 months
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Viral Load
Time frame: 6 months
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Viral Load
Time frame: 9 months
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Viral Load
Time frame: 12 months
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Viral Load
Time frame: 15 months
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Viral Load
Time frame: 18 months
Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Laboratory Parameter Blood Glucose
Time frame: Baseline, 9 months, 18 months
Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Laboratory Parameter Transaminases
Time frame: Baseline, 9 months, 18 months
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Laboratory Parameter Lipids
Time frame: Baseline, 9 months, 18 months
A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
5 secondary outcomes
Reasons for Discontinuation of Lopinavir/Ritonavir
Time frame: 9 months
Reasons for Discontinuation of Lopinavir/Ritonavir
Time frame: 18 months
Compliance With Lopinavir/Ritonavir
Time frame: 9 months
Compliance With Lopinavir/Ritonavir
Time frame: 18 months
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maja Hojnik, MD, PhD study director
Abbott International
103 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 Patients, run by Abbott at 103 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in Russia, Poland, Romania, Ukraine, Czechia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4 Count (time frame: Baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2011.