Drug Use Investigation of Kaletra

Abbott

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Lopinavir/ritonavir (Kaletra)

Study type: Observational

Funder types: Industry

Identifiers

NCT01076972

PMOS-JAP-00-001

Details and patient eligibility

About

This non-interventional, post-marketing observational study was conducted to obtain data, such as safety and effectiveness, from the use of lopinavir/ritonavir (Kaletra) in clinical practice and investigate the necessity to conduct a follow-up post-marketing clinical study in Japan.

Enrollment: 1,184 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients prescribed Kaletra for the treatment of HIV are eligible for this survey.

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

1,184 participants in 1 patient group

Lopinavir/ritonavir group

Description:

All patients in this non-interventional, 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)