Kaletra: Therapy With Double Protease Inhibitors

AbbVie

Status: Completed

Conditions: Human Immunodeficiency Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT01075191

P05-103

Details and patient eligibility

About

Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

Full description

This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with Human Immunodeficiency Virus infection
• Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor

Exclusion criteria

• Hypersensitivity against lopinavir, ritonavir or other ingredients
• Severe liver insufficiency
• No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort

Trial design

65 participants in 1 patient group

HIV-infected participants

Description:

HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily).