Human Immunodeficiency VirusNCT01075191

Kaletra: Therapy With Double Protease Inhibitors

An observational study of Human Immunodeficiency Virus, run by AbbVie (prior sponsor, Abbott) at 17 sites in Germany.

Completed

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

Trial summary

Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus
Type of treatment: Pill or oral medicine
How many people: 65 participants
Where: 17 sitesGermany
Study dates: Jan 2004to Sep 2011
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: Community sample; Human Immunodeficiency Virus-infected participants

Who may be able to join

Participants with Human Immunodeficiency Virus infection
Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor

Who cannot join

Hypersensitivity against lopinavir, ritonavir or other ingredients
Severe liver insufficiency
No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Germany17 sites

Site Reference ID/Investigator# 48283
Berlin, 10439
Site Reference ID/Investigator# 28131
Berlin, 10551
Site Reference ID/Investigator# 66422
Berlin, 10961
Site Reference ID/Investigator# 28123
Berlin, 13347
Site Reference ID/Investigator# 28109
Berlin, D-10243
Site Reference ID/Investigator# 28115
Dortmund, 44137
Site Reference ID/Investigator# 28124
Frankfurt, 60311
Site Reference ID/Investigator# 28127
Frankfurt, 60329
Site Reference ID/Investigator# 28119
Frankfurt, 60596
Site Reference ID/Investigator# 5318
Krefeld, 47800
Site Reference ID/Investigator# 28112
Ludwigshafen, 67063
Site Reference ID/Investigator# 28118
Munich, 80337
Site Reference ID/Investigator# 28113
Munich, 80801
Site Reference ID/Investigator# 28111
Münster, 48143
Site Reference ID/Investigator# 28129
Münster, 48149
Site Reference ID/Investigator# 28133
Stuttgart, 70197
Site Reference ID/Investigator# 28126
Wuppertal, 42277

Other trials in Germany

About this study

Official title: PMOS: Kaletra Double Protease Inhibitors

Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

Read the detailed description

This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.

Conditions: Human Immunodeficiency Virus
Keywords: Viral load, Resistance, Double protease inhibitors, Mutations, Immune system, Infection, Nucleoside Reverse Transcriptase Inhibitors-free, Human Immunodeficiency Virus
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.

Study groups in NCT01075191
Study group	Role	What they receive
HIV-infected participants		HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily).

What is being measured

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

Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Viral load (number of HIV-1 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. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.
Measured: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Secondary outcomes (5)

Change From Baseline in Absolute CD4 Cell 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 (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Relative CD4 Cell Count
Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) 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 percentage of CD4+ cells at scheduled study visits.
Measured: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Absolute CD8 Cell Count
Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.
Measured: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Relative CD8 Cell Count
Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.
Measured: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in CD4/CD8 T-cell Ratio
The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.
Measured: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Timeline

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

Jan 2004Sep 2011

First posted25 Feb 2010 (estimated)
Study startJan 2004
Primary completionSep 2011
Study completionSep 2011

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: Cohort
Time perspective: Prospective
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01075191
Sponsor's protocol ID: P05-103
Status last verified: Jan 2013
First submitted: 23 Feb 2010
Last updated: 18 Jan 2013
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 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PMOS: Kaletra Double Protease Inhibitors
ClinicalTrials.gov ID: NCT01075191
Acronym / sponsor ID: P05-103
Conditions: Human Immunodeficiency Virus
Keywords: Viral load, Resistance, Double protease inhibitors, Mutations, Immune system, Infection, Nucleoside Reverse Transcriptase Inhibitors-free, Human Immunodeficiency Virus
Study type: Observational
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 25 Feb 2010 (estimated)
Results: Posted 30 Oct 2012

Clinical summary

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

Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
HIV-infected participants	–	–HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Community sample; Human Immunodeficiency Virus-infected participants

Key inclusion criteria (2 listed)

Participants with Human Immunodeficiency Virus infection
Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor

Key exclusion criteria (3 listed)

Hypersensitivity against lopinavir, ritonavir or other ingredients
Severe liver insufficiency
No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort

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

Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Viral load (number of HIV-1 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. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.

5 secondary outcomes

Change From Baseline in Absolute CD4 Cell Count
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Relative CD4 Cell Count
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Absolute CD8 Cell Count
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Relative CD8 Cell Count
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in CD4/CD8 T-cell Ratio
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Results and safety

Results posted to the registry on 30 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV-infected Participants	60	42

Primary outcome: Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL

Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144. Number. Unit: percentage of participants

Measure	HIV-infected Participants n = 60
Baseline (n=58)	8.6
Week 4 (n=42)	26.2
Week 12 (n=50)	40.0
Week 24 (n=48)	56.3
Week 36 (n=42)	69.1
Week 48 (n=41)	65.9
Week 60 (n=38)	68.4
Week 72 (n=38)	76.3

Population analysed: Evaluable participants. n=number of evaluable participants with given measurement at time point.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV-infected Participants	4 of 65 (6.2%)	0 of 65 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

AbbVie Deutschland GmbH & Co. KG, Medical Department

17 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 AbbVie (prior sponsor, Abbott) at 17 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 3 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 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 30 Oct 2012). 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?

Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL (time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144). 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 NCT01075191.

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 18 Jan 2013; AzTrials last refreshed its copy on 1 Nov 2026.