Surveillance of Kaletra in Korean Patients

An observational study of HIV-1 Infection, 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

This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling in participants 2 years of age and older with human immunodeficiency virus type 1 (HIV-1) infection. Read more about this study

Who is it for?: Ages 2 to 99 years
Conditions the study is for: HIV-1 Infection
Type of treatment: Pill or oral medicine
How many people: 595 participants
Where: No sites listed yet
Study dates: Oct 2009to Oct 2014
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 to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: general hospitals

Who may be able to join

Patients 2 years of age and above with HIV-1 infection
Patients who were prescribed Kaletra treatment as per investigator's medical judgment
Patients who gave verbal or written authorization to use their personal and health data
Patients who started Kaletra treatment after study agreement was in place

Who cannot join

Patients with known hypersensitivity to lopinavir, ritonavir or any excipients of the Kaletra tablet
Patients who were being treated or will be treated with drugs that are contraindicated with Kaletra
Patients who have been treated with Kaletra
Patients participating in other clinical trials

About this study

Official title: Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients Under the "New Drug Re-Examination"

Read the detailed description

Participants were observed for up to 48 weeks following the first dose of Kaletra. A follow-up visit took place 1-2 weeks after treatment initiation, and subsequent visits occurred at the discretion of the investigators, typically occurring every 3 months. Clinical/immunological/virological/laboratory status, Kaletra-containing regimen/concomitant medication information, and adverse event information were obtained at follow-up visits.

Conditions: HIV-1 Infection
Keywords: Postmarketing Drug Surveillance, HIV-1 infection, Kaletra

What participants receive

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

Study groups in NCT01083173
Study group	Role	What they receive
Participants with HIV-1 infection		Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet

What is being measured

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

Number of Participants With Adverse Events
Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.
Measured: From the start of treatment until 30 days after the last dose, up to 52 weeks
Number of Participants Who Interrupted or Discontinued Kaletra Treatment
At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).
Measured: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment
Percentage of Participants With Viral Load Below 400 Copies/mL
Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
Measured: Week 24
Percentage of Participants With Viral Load Below 50 Copies/mL
Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
Measured: Week 48

Secondary outcomes (4)

Change From Baseline in Viral Load
This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.
Measured: Week 24 & 48
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts
Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks.
Measured: From baseline to Weeks 24 and 48
Percentage of Participants With Confirmed Viral Resistance
Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance.
Measured: From baseline through weeks 24 and 48
Mean Time to Treatment Failure
Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48.
Measured: From baseline through weeks 24 and 48

Timeline

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

Oct 2009Oct 2014

First posted9 Mar 2010 (estimated)
Study startOct 2009
Primary completionOct 2014
Study completionOct 2014

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 InfectionStudies 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: 595 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083173
Sponsor's protocol ID: P11-068
Status last verified: Jan 2016
First submitted: 19 Feb 2010
Last updated: 22 Feb 2016
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

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients Under the "New Drug Re-Examination"
ClinicalTrials.gov ID: NCT01083173
Acronym / sponsor ID: P11-068
Conditions: HIV-1 Infection
Keywords: Postmarketing Drug Surveillance, HIV-1 infection, Kaletra
Study type: Observational
Recruitment status: Completed
Enrolment: 595 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 9 Mar 2010 (estimated)
Results: Posted 22 Feb 2016

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: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants with HIV-1 infection	–	–Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet

Who may qualify

Ages: 2 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: general hospitals

Key inclusion criteria (4 listed)

Patients 2 years of age and above with HIV-1 infection
Patients who were prescribed Kaletra treatment as per investigator's medical judgment
Patients who gave verbal or written authorization to use their personal and health data
Patients who started Kaletra treatment after study agreement was in place

Key exclusion criteria (4 listed)

Patients with known hypersensitivity to lopinavir, ritonavir or any excipients of the Kaletra tablet
Patients who were being treated or will be treated with drugs that are contraindicated with Kaletra
Patients who have been treated with Kaletra
Patients participating in other clinical trials

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

Number of Participants With Adverse Events
Time frame: From the start of treatment until 30 days after the last dose, up to 52 weeks
Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.
Number of Participants Who Interrupted or Discontinued Kaletra Treatment
Time frame: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment
At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).
Percentage of Participants With Viral Load Below 400 Copies/mL
Time frame: Week 24
Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
Percentage of Participants With Viral Load Below 50 Copies/mL
Time frame: Week 48
Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.

4 secondary outcomes

Change From Baseline in Viral Load
Time frame: Week 24 & 48
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts
Time frame: From baseline to Weeks 24 and 48
Percentage of Participants With Confirmed Viral Resistance
Time frame: From baseline through weeks 24 and 48
Mean Time to Treatment Failure
Time frame: From baseline through weeks 24 and 48

Results and safety

Results posted to the registry on 22 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main Surveillance	595	580
Long-term Surveillance	0	0

Primary outcome: Number of Participants With Adverse Events

Time frame: From the start of treatment until 30 days after the last dose, up to 52 weeks. Number. Unit: participants

Measure	Main Surveillance n = 580	Long-term Surveillance n = 479
Value	363	285

Population analysed: Participants with available data

Primary outcome: Number of Participants Who Interrupted or Discontinued Kaletra Treatment

Time frame: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment. Number. Unit: participants

Measure	Main Surveillance n = 580	Long-term Surveillance n = 479
Value	120	43

Population analysed: Participants with available data

Primary outcome: Percentage of Participants With Viral Load Below 400 Copies/mL

Time frame: Week 24. Number. Unit: percentage of participants

Measure	Main Surveillance n = 198
Value	92.4

Population analysed: Participants with available data

Primary outcome: Percentage of Participants With Viral Load Below 50 Copies/mL

Time frame: Week 48. Number. Unit: percentage of participants

Measure	Long-term Surveillance n = 102
Value	68.6

Population analysed: Participants with available data

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of treatment until 30 days after the last dose, up to 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Surveillance	51 of 580 (8.8%)	222 of 580 (38.3%)	Not reported
Long-term Surveillance	39 of 479 (8.1%)	169 of 479 (35.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for HIV-1 Infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

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.

SoRa Lee, MD study director

AbbVie Ltd.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV-1 Infection, 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 4 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 22 Feb 2016. 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 22 Feb 2016). 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 Participants With Adverse Events (time frame: From the start of treatment until 30 days after the last dose, up to 52 weeks). The study lists 4 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 NCT01083173.

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 22 Feb 2016.