Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection

AbbVie

Status: Completed

Conditions: Human Immunodeficiency Virus Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01328158

P12-760

Details and patient eligibility

About

This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:

1. Incidence and conditions of occurrence of adverse reactions in the clinical setting
2. Factors that may affect the safety and effectiveness of Kaletra (QD)

Enrollment: 236 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.

Exclusion criteria

• Participants with a history of hypersensitivity to any ingredient of this drug.
• Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.

Trial design

236 participants in 1 patient group

Lopinavir/Ritonavir

Description:

Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated