Special Investigation of Kaletra in Pregnant Women
This non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Special Investigation of Kaletra in Pregnant Women|
- Number of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: During pregnancy and for one year after birth ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||December 2000|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076985
|Site Reference ID/Investigator# 35862|
|Site Reference ID/Investigator# 35863|
|Site Reference ID/Investigator# 35864|
|Site Reference ID/Investigator# 5326|
|Site Reference ID/Investigator# 35865|
|Study Director:||Toshiro Maeda||Abbott Japan Co.,Ltd|