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Special Investigation of Kaletra in Pregnant Women

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ClinicalTrials.gov Identifier: NCT01076985
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : January 18, 2012
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus
Intervention Drug: Lopinavir/ritonavir (Kaletra)
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
30
(21 to 41)
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
30  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
24
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 24 participants
24
1.Primary Outcome
Title Number of Patients With Adverse Drug Reactions (ADRs)
Hide Description The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.
Time Frame During pregnancy and for one year after birth
Hide Outcome Measure Data
Hide Analysis Population Description
All available observed data for all participants and their resulting infants/live births are included.
Arm/Group Title Lopinavir/Ritonavir Infants
Hide Arm/Group Description:
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 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 and participated in this noninterventional, post-marketing observational study.
Overall Number of Participants Analyzed 24 21
Measure Type: Number
Unit of Measure: participants
Anemia 2 5
Hypercholesterolemia 1 0
Hyperlipidemia 1 0
Diarrhea 1 0
Nausea 2 0
Rash 1 1
Abortion missed 1 0
Premature labor 1 0
Threatened labor 1 0
Neutropenia 0 1
Hypoglycemia 0 1
Cardio-respiratory arrest 0 1
Apnea 0 1
Neonatal respiratory distress syndrome 0 1
Transient tachypnea of the newborn 0 1
Small for dates baby 0 1
Pyrexia 0 1
Time Frame All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lopinavir/Ritonavir Group Infants
Hide Arm/Group Description 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 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.
All-Cause Mortality
Lopinavir/Ritonavir Group Infants
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lopinavir/Ritonavir Group Infants
Affected / at Risk (%) Affected / at Risk (%)
Total   3/24 (12.50%)   3/21 (14.29%) 
Cardiac disorders     
Cardio-respiratory arrest * 1  0/24 (0.00%)  1/21 (4.76%) 
Pregnancy, puerperium and perinatal conditions     
Abortion missed * 1  1/24 (4.17%)  0/21 (0.00%) 
Premature labor * 1  1/24 (4.17%)  0/21 (0.00%) 
Threatened labor * 1  1/24 (4.17%)  0/21 (0.00%) 
Small for dates baby * 1  0/24 (0.00%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Neonatal respiratory distress syndrome * 1  0/24 (0.00%)  1/21 (4.76%) 
Upper respiratory tract inflammation * 1  0/24 (0.00%)  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lopinavir/Ritonavir Group Infants
Affected / at Risk (%) Affected / at Risk (%)
Total   11/24 (45.83%)   10/21 (47.62%) 
Blood and lymphatic system disorders     
Anemia * 1  6/24 (25.00%)  10/21 (47.62%) 
Neutropenia * 1  0/24 (0.00%)  1/21 (4.76%) 
Gastrointestinal disorders     
Diarrhea * 1  1/24 (4.17%)  0/21 (0.00%) 
Nausea * 1  2/24 (8.33%)  0/21 (0.00%) 
General disorders     
Pyrexia * 1  0/24 (0.00%)  1/21 (4.76%) 
Investigations     
Haemoglobin decreased * 1  0/24 (0.00%)  2/21 (9.52%) 
Metabolism and nutrition disorders     
Hypercholesterolemia * 1  1/24 (4.17%)  0/21 (0.00%) 
Hyperlipidemia * 1  1/24 (4.17%)  0/21 (0.00%) 
Hypoglycemia * 1  0/24 (0.00%)  2/21 (9.52%) 
Pregnancy, puerperium and perinatal conditions     
Large for dates baby * 1  0/24 (0.00%)  1/21 (4.76%) 
Psychiatric disorders     
Mental disorder * 1  1/24 (4.17%)  0/21 (0.00%) 
Reproductive system and breast disorders     
Breast enlargement * 1  1/24 (4.17%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Apnea * 1  0/24 (0.00%)  1/21 (4.76%) 
Transient tachypnea of the newborn * 1  0/24 (0.00%)  1/21 (4.76%) 
Skin and subcutaneous tissue disorders     
Rash * 1  1/24 (4.17%)  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Layout table for additonal information
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