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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
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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
  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.
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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 
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
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Time Frame All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0  

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.
Infants Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.

Other Adverse Events
    Lopinavir/Ritonavir Group   Infants
Total, other (not including serious) adverse events     
# participants affected / at risk   11/24 (45.83%)   10/21 (47.62%) 
Blood and lymphatic system disorders     
Anemia * 1     
# participants affected / at risk   6/24 (25.00%)   10/21 (47.62%) 
Neutropenia * 1     
# participants affected / at risk   0/24 (0.00%)   1/21 (4.76%) 
Gastrointestinal disorders     
Diarrhea * 1     
# participants affected / at risk   1/24 (4.17%)   0/21 (0.00%) 
Nausea * 1     
# participants affected / at risk   2/24 (8.33%)   0/21 (0.00%) 
General disorders     
Pyrexia * 1     
# participants affected / at risk   0/24 (0.00%)   1/21 (4.76%) 
Investigations     
Haemoglobin decreased * 1     
# participants affected / at risk   0/24 (0.00%)   2/21 (9.52%) 
Metabolism and nutrition disorders     
Hypercholesterolemia * 1     
# participants affected / at risk   1/24 (4.17%)   0/21 (0.00%) 
Hyperlipidemia * 1     
# participants affected / at risk   1/24 (4.17%)   0/21 (0.00%) 
Hypoglycemia * 1     
# participants affected / at risk   0/24 (0.00%)   2/21 (9.52%) 
Pregnancy, puerperium and perinatal conditions     
Large for dates baby * 1     
# participants affected / at risk   0/24 (0.00%)   1/21 (4.76%) 
Psychiatric disorders     
Mental disorder * 1     
# participants affected / at risk   1/24 (4.17%)   0/21 (0.00%) 
Reproductive system and breast disorders     
Breast enlargement * 1     
# participants affected / at risk   1/24 (4.17%)   0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Apnea * 1     
# participants affected / at risk   0/24 (0.00%)   1/21 (4.76%) 
Transient tachypnea of the newborn * 1     
# participants affected / at risk   0/24 (0.00%)   1/21 (4.76%) 
Skin and subcutaneous tissue disorders     
Rash * 1     
# participants affected / at risk   1/24 (4.17%)   1/21 (4.76%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (13.1)



  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