Special Investigation of Kaletra in Pregnant Women

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01076985

First received: February 25, 2010

Last updated: December 9, 2011

Last verified: December 2011

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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Baseline Characteristics

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Reporting Groups

	Description
Lopinavir/Ritonavir Group	All pregnant women in this noninterventional, 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]	24
Age [units: years] Median ( Full Range )	30 ( 21 to 41 )
Age [units: years] Mean ± Standard Deviation	30 ± 5.7
Gender [units: participants]
Female	24
Male	0
Region of Enrollment [units: participants]
Japan	24

Outcome Measures

1. Primary:

Number of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: During pregnancy and for one year after birth ]

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Serious Adverse Events

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Other Adverse Events

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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:	NCT01076985 History of Changes
Other Study ID Numbers:	PMOS-JAP-00-002
Study First Received:	February 25, 2010
Results First Received:	December 9, 2011
Last Updated:	December 9, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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