Special Investigation of Kaletra in Pregnant Women

Abbott

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Lopinavir/ritonavir (Kaletra)

Study type: Observational

Funder types: Industry

Identifiers

NCT01076985

PMOS-JAP-00-002

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Lopinavir/ritonavir group

Description:

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.

Treatment:

Drug: Lopinavir/ritonavir (Kaletra)