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