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
|Condition or disease||Intervention/treatment|
|Human Immunodeficiency Virus||Drug: Lopinavir/ritonavir (Kaletra)|
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Special Investigation of Kaletra in Pregnant Women|
|Study Start Date :||December 2000|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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.
Drug: Lopinavir/ritonavir (Kaletra)
Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
- Number of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: During pregnancy and for one year after birth ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076985
|Site Reference ID/Investigator# 35862|
|Site Reference ID/Investigator# 35863|
|Site Reference ID/Investigator# 35864|
|Site Reference ID/Investigator# 35865|
|Site Reference ID/Investigator# 5326|
|Study Director:||Toshiro Maeda||Abbott Japan Co.,Ltd|