Special Investigation of Kaletra in Pregnant Women
Information source: Abbott
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus
Phase: N/A
Status: Recruiting
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Toshiro Maeda, Study Director, Affiliation: Abbott Japan Co.,Ltd
Overall contact:
Abbott Japan PMOS Desk, Phone: +81-3-4588-4621, Email: ABTJ-PMOS@abbott.com
Summary
To detect and check the proper use information, such as efficacy and safety, of the product
in pregnant women and their children
Clinical Details
Official title: Special Investigation of Kaletra in Pregnant Women
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Evaluation of adverse event (occurrence of adverse event (yes or no), date of onset, diagnosis or definite symptom, details of symptom/course/intervention, seriousness, intensity, outcome, relationship to disease and drugs used)
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- All pregnant women who have received the Kaletra
Exclusion Criteria:
- 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
Locations and Contacts
Abbott Japan PMOS Desk, Phone: +81-3-4588-4621, Email: ABTJ-PMOS@abbott.com
Site Reference ID/Investigator# 35862, Aichi, Japan; Recruiting
Site Reference ID/Investigator# 35862, Principal Investigator
Site Reference ID/Investigator# 35863, Okayama, Japan; Recruiting
Site Reference ID/Investigator# 35863, Principal Investigator
Site Reference ID/Investigator# 35864, Osaka, Japan; Recruiting
Site Reference ID/Investigator# 35864, Principal Investigator
Site Reference ID/Investigator# 5326, Tokyo, Japan; Recruiting
Site Reference ID/Investigator# 5326, Principal Investigator
Site Reference ID/Investigator# 35865, Tokyo, Japan; Recruiting
Site Reference ID/Investigator# 35865, Principal Investigator
Additional Information
Starting date: December 2000
Last updated: August 3, 2010
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