Drug Use Investigation of Kaletra

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01076972

First received: February 25, 2010

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Results First Received: December 9, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Human Immunodeficiency Virus
Intervention:	Drug: Lopinavir/ritonavir (Kaletra)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Lopinavir/Ritonavir Group	All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Participant Flow: Overall Study

	Lopinavir/Ritonavir Group
STARTED	1184
COMPLETED	1184
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Lopinavir/Ritonavir Group	All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Baseline Measures

	Lopinavir/Ritonavir Group
Number of Participants [units: participants]	1184
Age [units: years] Mean ± Standard Deviation	39.7 ± 11.0
Age, Customized [units: participants]
<=14 years	4
Between 15 and 64 years	1155
>=65 years	25
Gender [units: participants]
Female	106
Male	1078
Region of Enrollment [units: participants]
Japan	1184

Outcome Measures

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1. Primary:

Total Number of Patients With Adverse Drug Reactions [ Time Frame: During the course of the survey period up to Year 8 ]

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2. Primary:

Cluster of Differentiation 4 Lymphocyte Count (CD4) [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]

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3. Primary:

Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]

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4. Primary:

Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents [ Time Frame: Baseline (Month 0) and following last treatment dose during the course of the survey period ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	During the course of the survey period up to Year 8.
Additional Description	Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in > 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Lopinavir/Ritonavir Group	All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Other Adverse Events

	Lopinavir/Ritonavir Group
Total, other (not including serious) adverse events
# participants affected / at risk	539/1184
Gastrointestinal disorders
Diarrhoea ^{* 1}
# participants affected / at risk	148/1184 (12.50%)
Nausea ^{* 1}
# participants affected / at risk	87/1184 (7.35%)
Investigations
Blood triglycerides increased ^{* 1}
# participants affected / at risk	104/1184 (8.78%)
Metabolism and nutrition disorders
Hypertriglyceridaemia ^{* 1}
# participants affected / at risk	77/1184 (6.50%)
Hyperlipidaemia ^{* 1}
# participants affected / at risk	230/1184 (19.43%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (13.1)

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01076972 History of Changes
Other Study ID Numbers:	PMOS-JAP-00-001
Study First Received:	February 25, 2010
Results First Received:	December 9, 2011
Last Updated:	January 31, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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