Human Immunodeficiency VirusNCT01083810

Evaluation of Kaletra Therapy Over the Long-term

An observational study of Human Immunodeficiency Virus, run by Abbott at 90 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Long term observation of patients under lopinavir/ritonavir containing therapy Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Lopinavir/Ritonavir (Kaletra)
Type of treatment: Pill or oral medicine
How many people: 284 participants
Where: 90 sitesGermany
Study dates: Jun 2001to Jun 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Human Immunodeficiency Virus-infected, protease inhibitor-naïve patients from a clinical setting

Who may be able to join

Patients infected by HIV-1
Age greater than or equal to 18 years

Who cannot join

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

Trial locations and contacts

90 sites in 1 country.

City, postcode or hospital

90 sites in 1 country

Germany90 sites

Site Ref # / Investigator 27706
Aachen, 52062
Site Ref # / Investigator 52972
Aachen, 52062
Site Ref # / Investigator 27660
Berlin, 10117
Site Ref # / Investigator 27937
Berlin, 10117
Site Ref # / Investigator 52973
Berlin, 10117
Site Reference ID/Investigator# 27629
Berlin, 10243
Site Ref # / Investigator 27651
Berlin, 10439
Site Ref # / Investigator 27912
Berlin, 10439
Site Reference ID/Investigator# 27544
Berlin, 10439
Site Reference ID/Investigator# 27567
Berlin, 10551
Site Ref # / Investigator 27929
Berlin, 10589
Site Ref # / Investigator 52971
Berlin, 10707
Site Ref # / Investigator 53468
Berlin, 10707
Site Ref # / Investigator 27965
Berlin, 10777
Site Reference ID/Investigator# 27547
Berlin, 10777
Site Reference ID/Investigator# 27552
Berlin, 10777
Site Reference ID/Investigator# 27562
Berlin, 10777
Site Ref # / Investigator 52984
Berlin, 10961
Site Ref # / Investigator 27639
Berlin, 13347
Site Ref # / Investigator 52970
Berlin, 13347
Site Ref # / Investigator 27909
Berlin, D-10243
Site Ref # / Investigator 47113
Berlin, D-10243
Site Reference ID/Investigator# 27574
Chemnitz, 09113
Site Ref # / Investigator 28060
Cologne, 50674
Site Ref # / Investigator 52978
Cologne, 50674
Site Ref # / Investigator 27932
Cologne, 50679
Site Ref # / Investigator 52979
Cologne, 50679
Site Ref # / Investigator 48233
Cologne, 50931
Site Ref # / Investigator 52985
Cologne, 50931
Site Ref # / Investigator 53464
Cologne, 50931
Site Ref # / Investigator 27704
Dortmund, 44137
Site Ref # / Investigator 27947
Dortmund, 44137
Site Ref # / Investigator 52968
Dortmund, 44137
Site Reference ID/Investigator# 27558
Duisburg, 47259
Site Ref # / Investigator 28056
Düsseldorf, 40237
Site Ref # / Investigator 52983
Frankfurt, 15232
Site Ref # / Investigator 27928
Frankfurt, 60311
Site Ref # / Investigator 52967
Frankfurt, 60311
Site Reference ID/Investigator# 27565
Freiburg im Breisgau, 79106
Site Reference ID/Investigator# 27566
Fürth, 90762
Site Ref # / Investigator 53465
Fürth, D-90762
Site Ref # / Investigator 27931
Hamburg, 20099
Site Ref # / Investigator 27982
Hamburg, 20099
Site Ref # / Investigator 47114
Hamburg, 20099
Site Ref # / Investigator 47115
Hamburg, 20099
Site Reference ID/Investigator# 27551
Hamburg, 20099
Site Reference ID/Investigator# 27634
Hamburg, 20099
Site Ref # / Investigator 30864
Hamburg, 20146
Site Ref # / Investigator 5348
Hamburg, 20146
Site Reference ID/Investigator# 27546
Hamburg, 20146
Site Ref # / Investigator 28032
Hamburg, 20246
Site Ref # / Investigator 52969
Hamburg, 20246
Site Ref # / Investigator 53467
Hamburg, 20246
Site Ref # / Investigator 52980
Hamburg, 20354
Site Ref # / Investigator 27641
Karlsruhe, 76135
Site Ref # / Investigator 27964
Karlsruhe, 76135
Site Reference ID/Investigator# 27561
Karlsruhe, 76135
Site Ref # / Investigator 53466
Koblenz, 56065
Site Reference ID/Investigator# 27555
Koblenz, 56065
Site Ref # / Investigator 27905
Krefeld, 47800
Site Ref # / Investigator 27906
Leipzig, 04107
Site Ref # / Investigator 52975
Leipzig, 04107
Site Ref # / Investigator 53463
Leipzig, 04107
Site Ref # / Investigator 27948
Ludwigshafen, 67063
Site Ref # / Investigator 52977
Ludwigshafen, 67063
Site Ref # / Investigator 27902
Mainz, 55116
Site Reference ID/Investigator# 27543
Mainz, 55116
Site Ref # / Investigator 28104
Mönchengladbach, 41061
Site Ref # / Investigator 52981
Mönchengladbach, 41061
Site Ref # / Investigator 27949
Munich, 80337
Site Reference ID/Investigator# 27553
Munich, 80337
Site Ref # / Investigator 27926
Munich, 80801
Site Ref # / Investigator 53462
Munich, 80801
Site Ref # / Investigator 27648
Münster, 48149
Site Reference ID/Investigator# 27568
Münster, 48149
Site Ref # / Investigator 52982
Nuremberg, 90419
Site Ref # / Investigator 27988
Oldenburg, 26121
Site Reference ID/Investigator# 27563
Oldenburg, 26121
Site Ref # / Investigator 27637
Osnabrück, 49076
Site Ref # / Investigator 27943
Osnabrück, 49076
Site Ref # / Investigator 52974
Osnabrück, 49076
Site Ref # / Investigator 27939
Paderborn, 33100
Site Ref # / Investigator 27649
Rostock, 18057
Site Reference ID/Investigator# 27569
Rostock, D-18057
Site Ref # / Investigator 27647
Stuttgart, 70197
Site Ref # / Investigator 28047
Stuttgart, 70197
Site Ref # / Investigator 28048
Stuttgart, 70197
Site Reference ID/Investigator# 27631
Stuttgart, 70197
Site Ref # / Investigator 52976
Troisdorf, 53840
Site Ref # / Investigator 27961
Wuppertal, 42277

Other trials in Germany

About this study

Long term observation of patients under lopinavir/ritonavir containing therapy

Read the 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.

Conditions: Human Immunodeficiency Virus
Being tested: Lopinavir/Ritonavir (Kaletra)
Keywords: Human Immunodeficiency Virus, Infection, Kaletra, Resistance, Mutations, alternative Therapy regimen
Medical subject headings: Acquired Immunodeficiency Syndrome, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lopinavir/Ritonavir (Kaletra)Drug
Also called ABT-378/r, Kaletra, Lopinavir/Ritonavir
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Study groups in NCT01083810
Study group	Role	What they receive
therapy-naive		Patients who had not received prior antiretroviral drug therapy Receives: Drug: Lopinavir/Ritonavir (Kaletra)
pre-treated		Patients that had previously received antiretroviral therapy, but are protease inhibitor naive Receives: Drug: Lopinavir/Ritonavir (Kaletra)
non-B		Patients infected with non-B subtypes of HIV-1 Receives: Drug: Lopinavir/Ritonavir (Kaletra)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.
Measured: Baseline and at any timepoint where testing is possible

Secondary outcomes (5)

Percentage of Patients With HIV-1 RNA <50 Copies/ml
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.
Measured: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.
Measured: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.
Measured: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA >500 Copies/ml
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.
Measured: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.
Measured: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2001Jun 2010

First posted10 Mar 2010 (estimated)
Study startJun 2001
Primary completionJun 2010
Study completionJun 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 Human Immunodeficiency VirusStudies 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
Observational model: Case only
Time perspective: Prospective
Enrolment: 284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083810
Sponsor's protocol ID: KAL 1 RO
Status last verified: Aug 2011
First submitted: 26 Feb 2010
Last updated: 11 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Kaletra Therapy Over the Long-term
ClinicalTrials.gov ID: NCT01083810
Acronym / sponsor ID: KAL 1 RO
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus, Infection, Kaletra, Resistance, Mutations, alternative Therapy regimen
Study type: Observational
Recruitment status: Completed
Enrolment: 284 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jun 2001
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 10 Mar 2010 (estimated)
Results: Posted 29 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Long term observation of patients under lopinavir/ritonavir containing therapy

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
therapy-naive	–	Drug: Lopinavir/Ritonavir (Kaletra)Patients who had not received prior antiretroviral drug therapy
pre-treated	–	Drug: Lopinavir/Ritonavir (Kaletra)Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
non-B	–	Drug: Lopinavir/Ritonavir (Kaletra)Patients infected with non-B subtypes of HIV-1

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Human Immunodeficiency Virus-infected, protease inhibitor-naïve patients from a clinical setting

Key inclusion criteria (2 listed)

Patients infected by HIV-1
Age greater than or equal to 18 years

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lopinavir/Ritonavir (Kaletra)Also: ABT-378/r, Kaletra, Lopinavir/Ritonavir3 capsules 2xdaily or 2 tablets 2xdaily Kaletra	Drug	non-B, pre-treated, therapy-naive

Primary outcome

Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Time frame: Baseline and at any timepoint where testing is possible
Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.

5 secondary outcomes

Percentage of Patients With HIV-1 RNA <50 Copies/ml
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

Results and safety

Results posted to the registry on 29 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Therapy-naive	137	72
Pre-treated	92	47
Non-B	55	35

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

Time frame: Baseline and at any timepoint where testing is possible. Number. Unit: Participants

Measure	Therapy-naive n = 137	Pre-treated n = 92	Non-B n = 55
Genotypic resistance testing performed at Baseline	137	68	55
Complete resistance testing results at Baseline	122	68	55
>Resistance to lopinavir/ritonavir at Baseline	0	2	0
>Partial resistance to NRTI at Baseline	5	0	0
>Partial resistance to NNRTI at Baseline	0	0	0
Underwent resistance testing at follow-up	2	2	2
>Resistance to lopinavir/ritonavir*	0	1	0
>>Resistance to NRTIs	0	1	0

Population analysed: All participants with resistance testing at baseline and follow-up are presented.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Investigators were instructed to report adverse events throughout the study (up to 5 years).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV-infected Patients	16 of 284 (5.6%)	56 of 284 (19.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.

Stefan Simianer, MD study director

Abbott Germany, Medical Department

90 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus, run by Abbott at 90 sites in Germany.

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 2 inclusion and 1 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 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in Germany. 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 29 Jul 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?

Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs (time frame: Baseline and at any timepoint where testing is possible). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01083810.

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 11 Aug 2011.