Human Immunodeficiency VirusPROTEKTNCT01076179

Kaletra in Combination With Antiretroviral Agents

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.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Human Immunodeficiency Virus
How many people: 502 participants
Where: No sites listed yet
Study dates: Sep 2008to 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-positive patients

Who may be able to join

Patients ≥ 18years of age
Written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the KALETRA® post marketing observational study)
HIV-1 infection
Patients treated with KALETRA®, independent from their participation in this study
Patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study

Who cannot join

Hypersensitivity against Kaletra or other ingredients or INIs or NNRTIs or CCR5 antagonists
Severe liver insufficiency
No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or St. John's wort

About this study

Official title: KALETRA in Combination With New Substances (PROTEKT)

The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with Kaletra.

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: Infection, Rilpivirine, CCR5 antagonists, Etravirine, Human Immunodeficiency Virus, Maraviroc, Safety and efficacy, Non nucleoside reverse transcriptase inhibitors (NNRTIs), Integrase inhibitors, Raltegravir, Kaletra
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 NCT01076179
Study group	Role	What they receive
Human Immunodeficiency Virus (HIV)-Infected Participants		HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists

What is being measured

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

Prevalence of Adverse Events (Weeks 0-144), Per Event
Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').
Measured: Weeks 0 to 144
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').
Measured: Weeks 0 to 144

Secondary outcomes (16)

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
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.
Measured: Baseline (Week 0) to Week 144
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.
Measured: Baseline (Week 0) to Week 144
Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL
Measured: From Week 0 to Week 144
Number of Participants With Lopinavir (LPV) Resistance at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.
Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: Baseline (Week 0)
Number of Participants With LPV Resistance During Follow-Up
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: up to Week 144
Number of Participants With Protease Inhibitor (PI) Resistance at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.
Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: Baseline (Week 0)
Number of Participants With PI Resistance During Follow-Up
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: Up to Week 144
Number of Participants With INI Resistance at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: Baseline (Week 0)
Number of Participants With INI Resistance During Follow-Up
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: up to Week 144
Number of Participants With NNRTI Resistance at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: Baseline (Week 0)
Number of Participants With NNRTI Resistance During Follow-Up
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: up to Week 144
Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: Baseline (Week 0)
Number of Participants With NRTI Resistance During Follow-Up
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Measured: up to Week 144
Number of Participants With HIV-1 Coreceptor Tropism at Baseline
Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline.
Measured: Baseline (Week 0)
Number of Participants With HIV-1 Coreceptor Tropism During Follow-up
Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up.
Measured: up to Week 144

Timeline

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

Sep 2008Jan 2016

First posted26 Feb 2010 (estimated)
Study startSep 2008
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: 502 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01076179
Sponsor's protocol ID: P11-021
Acronym: PROTEKT
Status last verified: May 2017
First submitted: 24 Feb 2010
Last updated: 19 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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Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: KALETRA in Combination With New Substances (PROTEKT)
ClinicalTrials.gov ID: NCT01076179
Acronym / sponsor ID: PROTEKT / P11-021
Conditions: Human Immunodeficiency Virus
Keywords: Infection, Rilpivirine, CCR5 antagonists, Etravirine, Human Immunodeficiency Virus, Maraviroc, Safety and efficacy, Non nucleoside reverse transcriptase inhibitors (NNRTIs)
Study type: Observational
Recruitment status: Completed
Enrolment: 502 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 26 Feb 2010 (estimated)
Results: Posted 19 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
Human Immunodeficiency Virus (HIV)-Infected Participants	–	–HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Community sample: HIV-positive patients

Key inclusion criteria (5 listed)

Patients ≥ 18years of age
Written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the KALETRA® post marketing observational study)
HIV-1 infection
Patients treated with KALETRA®, independent from their participation in this study
Patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study

Key exclusion criteria (3 listed)

Hypersensitivity against Kaletra or other ingredients or INIs or NNRTIs or CCR5 antagonists
Severe liver insufficiency
No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or 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

Prevalence of Adverse Events (Weeks 0-144), Per Event
Time frame: Weeks 0 to 144
Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Time frame: Weeks 0 to 144
Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').

16 secondary outcomes

Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Time frame: Baseline (Week 0) to Week 144
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Time frame: Baseline (Week 0) to Week 144
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Time frame: Baseline (Week 0) to Week 144
Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL
Time frame: From Week 0 to Week 144
Number of Participants With Lopinavir (LPV) Resistance at Baseline
Time frame: Baseline (Week 0)
Number of Participants With LPV Resistance During Follow-Up
Time frame: up to Week 144
Number of Participants With Protease Inhibitor (PI) Resistance at Baseline
Time frame: Baseline (Week 0)
Number of Participants With PI Resistance During Follow-Up
Time frame: Up to Week 144
Number of Participants With INI Resistance at Baseline
Time frame: Baseline (Week 0)
Number of Participants With INI Resistance During Follow-Up
Time frame: up to Week 144
Number of Participants With NNRTI Resistance at Baseline
Time frame: Baseline (Week 0)
Number of Participants With NNRTI Resistance During Follow-Up
Time frame: up to Week 144
Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline
Time frame: Baseline (Week 0)
Number of Participants With NRTI Resistance During Follow-Up
Time frame: up to Week 144
Number of Participants With HIV-1 Coreceptor Tropism at Baseline
Time frame: Baseline (Week 0)
Number of Participants With HIV-1 Coreceptor Tropism During Follow-up
Time frame: up to Week 144

Results and safety

Results posted to the registry on 19 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	502	501

Primary outcome: Prevalence of Adverse Events (Weeks 0-144), Per Event

Time frame: Weeks 0 to 144. Number. Unit: percentage of adverse events

Measure	HIV-infected Participants n = 501
Hypertriglyceridemia	13.8
Hypercholesterolemia	19.3
Low HDL Cholesterol	1.0
High LDL Cholesterol	4.4
Hyperglycemia	1.6
Hyperbilirubinemia	1.8
Elevated AST	3.4
Elevated ALT	4.6

Primary outcome: Prevalence of Adverse Events (Weeks 0-144), Per Participant

Time frame: Weeks 0 to 144. Number. Unit: percentage of participants

Measure	HIV-infected Participants n = 501
Hypertriglyceridemia	14.8
Hypercholesterolemia	17.8
Low HDL Cholesterol	3.0
High LDL Cholesterol	7.2
Hyperglycemia	2.8
Hyperbilirubinemia	2.8
Elevated AST	5.0
Elevated ALT	6.4

16 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
HIV-infected Participants	30 of 501 (6%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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.

Bianca Wittig, 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 5 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 19 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 19 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?

Prevalence of Adverse Events (Weeks 0-144), Per Event (time frame: Weeks 0 to 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 NCT01076179.

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 19 May 2017.