Special Investigation of Kaletra in Pregnant Women

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
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
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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.
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Reporting Groups
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]
[units: years]
Median (Full Range)
  30   (21 to 41)  
[units: years]
Mean (Standard Deviation)
  30  (5.7)  
[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

  Limitations and Caveats
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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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  More Information