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
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


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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
No text entered.  


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