Special Investigation of Kaletra in Pregnant Women
1 other identifier
observational
24
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2000
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
January 18, 2012
CompletedJanuary 18, 2012
December 1, 2011
10 years
February 25, 2010
December 9, 2011
December 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Adverse Drug Reactions (ADRs)
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.
During pregnancy and for one year after birth
Study Arms (1)
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.
Interventions
Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
Eligibility Criteria
Hospital
You may qualify if:
- All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study
You may not qualify if:
- Contraindications according to the Package Insert:
- Patients with a history of hypersensitivity to any ingredient of Kaletra
- Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (5)
Site Reference ID/Investigator# 35862
Aichi, Japan
Site Reference ID/Investigator# 35863
Okayama, Japan
Site Reference ID/Investigator# 35864
Osaka, Japan
Site Reference ID/Investigator# 35865
Tokyo, Japan
Site Reference ID/Investigator# 5326
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Toshiro Maeda
Abbott Japan Co.,Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2010
First Posted
February 26, 2010
Study Start
December 1, 2000
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 18, 2012
Results First Posted
January 18, 2012
Record last verified: 2011-12