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Special Investigation of Kaletra in Pregnant Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076985
First Posted: February 26, 2010
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott
Results First Submitted: 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
No text entered.

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 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 
NOT COMPLETED   0 



  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.
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 
Overall Participants Analyzed 
[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


  Limitations and Caveats


  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.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110



Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01076985     History of Changes
Other Study ID Numbers: PMOS-JAP-00-002
First Submitted: February 25, 2010
First Posted: February 26, 2010
Results First Submitted: December 9, 2011
Results First Posted: January 18, 2012
Last Update Posted: January 18, 2012