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
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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
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.

Participant Flow:   Overall Study
    Lopinavir/Ritonavir Group  
STARTED     24  
COMPLETED     24  

  Baseline Characteristics

  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