Human Immunodeficiency VirusNCT01097655

Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet

An observational study of Human Immunodeficiency Virus, run by AbbVie (prior sponsor, Abbott).

Completed

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

Trial summary

The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Human Immunodeficiency Virus
Type of treatment: Pill or oral medicine
How many people: 3,049 participants
Where: No sites listed yet
Study dates: Aug 2006to Jan 2016
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: * Community sample; HIV-infected patients * For Belgium: AIDS references centers (probability sample)

Who may be able to join

Patients with HIV infection
Patients that will be treated with Kaletra tablets independent from their participation in this study

Who cannot join

Hypersensitivity against Kaletra or other ingredients
Severe liver insufficiency
No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
Patients who received more than 1 protease inhibitor during their therapy history

About this study

Official title: Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort

Read the detailed description

This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Conditions: Human Immunodeficiency Virus
Keywords: Tablets, Infection, Non Nucleoside Reverse Transcriptase Inhibitor, Tolerability, Viral load, Human immunodeficiency Virus, Effectiveness, Treatment-naïve
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 NCT01097655
Study group	Role	What they receive
HIV-infected Participants		HIV-infected participants starting with Kaletra tablets. Participants included 3 subgroups: * antiretroviral therapy (ART) treatment-naïve participants starting with Kaletra tablets * participants receiving their first protease inhibitor (PI)-containing regimen (apart from Kaletra) pretreated with any non nucleoside reverse transcriptase inhibitor (NNRTI)-containing or nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen * participants pretreated with a PI-containing regimen (apart from Kaletra).

What is being measured

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

Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.
Measured: Baseline (Week 0) to Week 144
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.
Measured: Baseline (Week 0) to Week 144

Timeline

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

Aug 2006Jan 2016

First posted2 Apr 2010 (estimated)
Study startAug 2006
Primary completionJan 2016
Study completionJan 2016

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: 3,049 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01097655
Sponsor's protocol ID: P06-131
Status last verified: May 2017
First submitted: 26 Feb 2010
Last updated: 23 May 2017
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?

Official record

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort
ClinicalTrials.gov ID: NCT01097655
Acronym / sponsor ID: P06-131
Conditions: Human Immunodeficiency Virus
Keywords: Tablets, Infection, Non Nucleoside Reverse Transcriptase Inhibitor, Tolerability, Viral load, Human immunodeficiency Virus, Effectiveness, Treatment-naïve
Study type: Observational
Recruitment status: Completed
Enrolment: 3,049 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Veeda Clinical Research
Study start: Aug 2006
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 2 Apr 2010 (estimated)
Results: Posted 23 May 2017

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
HIV-infected Participants	–	–HIV-infected participants starting with Kaletra tablets. Participants included 3 subgroups: * antiretroviral therapy (ART) treatment-naïve participants starting with Kaletra tablets * participants receiving their first protease inhibitor (PI)-containing regimen (apart from Kaletra) pretreated with any non nucleoside reverse transcriptase inhibitor (NNRTI)-containing or nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen * participants pretreated with a PI-containing regimen (apart from Kaletra).

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: * Community sample; HIV-infected patients * For Belgium: AIDS references centers (probability sample)

Key inclusion criteria (2 listed)

Patients with HIV infection
Patients that will be treated with Kaletra tablets independent from their participation in this study

Key exclusion criteria (4 listed)

Hypersensitivity against Kaletra or other ingredients
Severe liver insufficiency
No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
Patients who received more than 1 protease inhibitor during their therapy history

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

Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Time frame: Baseline (Week 0) to Week 144
Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Time frame: Baseline (Week 0) to Week 144
Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.

Results and safety

Results posted to the registry on 23 May 2017, 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	3,049	3,039

Primary outcome: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count

Time frame: Baseline (Week 0) to Week 144. Mean (Standard Deviation). Unit: cells/μL

Measure	HIV-infected Participants n = 2981
Change at Week 4	99.8 (145.2)
Change at Week 12	133.3 (148.7)
Change at Week 24	160.5 (177.6)
Change at Week 36	185.9 (181.2)
Change at Week 48	213.6 (225.1)
Change at Week 60	228.4 (204.6)
Change at Week 72	250.1 (205.1)
Change at Week 84	263.8 (214.8)

Population analysed: Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.

Primary outcome: Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load

Time frame: Baseline (Week 0) to Week 144. Mean (Standard Deviation). Unit: log copies/mL

Measure	HIV-infected Participants n = 2959
Change at Week 4	-1.90 (0.97)
Change at Week 12	-2.53 (1.23)
Change at Week 24	-2.83 (1.35)
Change at Week 36	-2.89 (1.40)
Change at Week 48	-2.89 (1.41)
Change at Week 60	-2.93 (1.38)
Change at Week 72	-2.92 (1.36)
Change at Week 84	-2.92 (1.37)

Population analysed: Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.

Adverse events

Time frame: Through Week 144. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV-infected Participants	79 of 3,039 (2.6%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Human Immunodeficiency Virus

RecruitingPhase 2
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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.

Sandra Bloch, MD study director

AbbVie Deutschland GmbH & Co. KG, Medical Department

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus, run by AbbVie (prior sponsor, Abbott).

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 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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 23 May 2017). 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?

Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count (time frame: Baseline (Week 0) to Week 144). The study lists 2 primary outcomes in all. 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 NCT01097655.

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 23 May 2017.