Overview

Special Investigation of Kaletra in Pregnant Women

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
Female
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abbott
Treatments:
Lopinavir
Ritonavir
Criteria
Inclusion Criteria:

- All pregnant women who have received Kaletra for the treatment of HIV infection were
eligible for this study

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